Resources

Resources

Our broad yet deep cross-disciplinary experience combined with the unique SPT Vilecon facilities allow us to move efficiently between high level consultancy, hands-on prototyping, and production.

A 360° coverrage

Our approach to incoming and ongoing projects

Tailored Expertise. Trusted Results.

At SPT Vilecon, our 360° project approach is rooted in strong values and decades of experience in the regulated medical industry. We manage every phase with precision, whether leading full-scale projects or delivering specialized services.

We focus on:

High-quality outcomes

Clear goals and fast execution

User-centered, compliant solutions

Our flexible services adapt to our partner's needs, always aligned with international standards and supported by our robust quality management system.

A complete development process

Our 8 phases

Ideas & Concept

Leveraging our deep industry insight and strong network, we support partners not only in product development but also in shaping solid business plans ensuring their innovations are both technically and commercially viable.

Product Specifications

The crucial part of the medical device design and development process is creating a product requirement to outline a product specification.

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Product Specifications

An outline of requirements

The crucial part of the medical device design and development process is creating a product requirement to outline a product specification.

Our approach is thorough. We collaborate closely with our clients to gather essential information, including regulatory requirements, user needs, and technical specifications. This ensures that all aspects of the product are clearly defined, enabling streamlined design and production processes while minimizing risks and ensuring compliance.

Business Planning

We assist in creating business plans that align with each partner and end user's unique needs and goals.

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Business Planning

Aligning strategic goals

We assist in creating business plans that align with each partner and end user's unique needs and goals.

Our services include comprehensive market and competitor analysis, detailed organizational management and offerings descriptions, funding requests, and financial projections. This holistic approach ensures that our client's business plans are robust and strategic.

Patents

We operate in a highly regulated and fast-moving industry that optimizes diagnostics, treatment, and overall patient care, and therefore, it's essential for our partners with patents.

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Patents

Assisting partners in protecting their inventions

We operate in a highly regulated and fast-moving industry that optimizes diagnostics, treatment, and overall patient care, and therefore, it's essential for our partners with patents.

As our partners, the driving force behind the MedTech industry, continue to innovate to keep up with the growing trend and better serve patients and the healthcare professionals who treat them, protecting our partners invention is crucial for us.

Mock-ups

Product design and prototyping during the development process's feasibility and design verification phases are interconnected processes essential to developing new devices.

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Mock-ups

Physical form and function test

Product design and prototyping during the development process's feasibility and design verification phases are interconnected processes essential to developing new devices.

Testing sizes, forms, and functions involve building physical or digital prototypes to test and evaluate various aspects of the design, with a particular focus on user interactions and manufacturing processes. By building mock-ups early in the development, we can make necessary refinements before moving forward with more detailed prototyping, ensuring a user-centric approach and preparing for production.

Feasibility & Piloting

At SPT Vilecon, we merge design, development, and electromechanics to create cutting-edge medical devices. With deep expertise in injection moulding, micromechanics, and user-centered design, we deliver smart, production-ready solutions always with quality, compliance, and innovation at the core.

3D print

3D print can be used in a variety of settings and we are keen on discovering opportunities and using latest technologies within the area.

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3D print

Function models and insert moulding

3D print can be used in a variety of settings and we are keen on discovering opportunities and using latest technologies within the area.

Rapid prototyping with in-house 3D printers empowers us to create prototypes within hours and carry out multiple iterations of form, size, function or assembly based on results of real-life testing and analysis. We use different techniques from FFF/FDM and SLA. Further we use the 3D printers to create moulds for testing injection moulding processes where we additionally try different materials such as silicones. We help clients move forward from initial ideas with low-risk concept models, proof-of-concept (POC) prototypes, and looks-like prototypes. 3D printing empowers us to go from CAD to physical object in short time.

Product Design - Verification and Validation

Evaluation of the design, materials specifications and safety, components design, manufacturing processes, and operational performance to see if the device meets the product requirements and design specifications.

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Product Design - Verification and Validation

Evaluation and control of a product design during its development

To ensure a product meets specific requirements, we assist our partners with technical reviews as part of product design verification and validation during its development. The product design verification process involves testing the product's functionality, performance, risk, and suitability for the market.

CAD Drawings

In the fast-paced medical device manufacturing and engineering industry, efficient communication is critical to success.

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CAD Drawings

2D/3D Drawings

In the fast-paced medical device manufacturing and engineering industry, efficient communication is critical to success.

As technology advances, so does how we communicate product information. 3D product drawings simplify communication by offering a common visual language that all stakeholders can easily understand. This type of communication reduces the possibility of misinterpretation and ensures everyone is on the same page. Our engineers harness the power of 3D drawing to meticulously design and rigorously test medical devices, encompassing MedTech Products and Medical Devices, thereby advancing the quality and effectiveness of healthcare.

Part Design

We develop injection moulds and injection moulding products to produce components in thermoplastics and silicones.

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Part Design

Multi-component Injection Moulding (2K + 3K)

We develop injection moulds and injection moulding products to produce components in thermoplastics and silicones.

Our multi-component injection moulding technology benefits our partners by enabling high process reliability and low production costs. Complex assembly of the individual injection moulding parts is no longer necessary.

Risk Assessment

Our approach to risk assessment is comprehensive and adaptable.

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Risk Assessment

Identifying and managing potential risks

Our approach to risk assessment is comprehensive and adaptable.

We assist our partners in identifying, understanding, and controlling potential failures that could lead to hazards when their devices or components are designed and manufactured. Depending on the contract, we help identify possible hazards associated with the design in both standard and faulty conditions. If any risk is deemed unacceptable, we work to reduce it to acceptable levels using appropriate means, ensuring our process is always tailored to your needs.

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Design for Manufacturing

In a fast-moving MedTech landscape, speed and precision are key. At SPT Vilecon, we Design For Manufacturing from day one, using advanced tools like rapid prototyping and moldflow analysis to ensure every solution is production-ready. Whether part of a full project or a standalone task, our equipment and fixtures are tested to deliver consistent quality and performance.

Moldflow Analysis

Leverage our Moldflowsimulation services to identify and solve potential moulding issues early,saving time and reducing costs

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Moldflow Analysis

Optimizing injection moulding

Leverage our Moldflowsimulation services to identify and solve potential moulding issues early,saving time and reducing costs

At SPT Vilecon, we provide Moldflow simulation services to optimize the injection moulding process. Our experts use Moldflow to identify design and manufacturing issues, such as flow imbalances, cooling inefficiencies, and warping before production begins. This early insight allows us to fine tune designs, adjust gating systems, and select the best materials, reducing prototyping costs and accelerating time-to-market. With Moldflow, we ensure high-quality, cost-effective moulded parts and smoother production cycles.

Manufacturing Optimization

Not only are products becoming more complex, but the process of building them at scale is becoming more complicated.

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Manufacturing Optimization

From prototype to mass production

Not only are products becoming more complex, but the process of building them at scale is becoming more complicated.

We help partners transform findings, data, and measurements into a solid and effective manufacturing process. To elevate our partners' potential, we operate fast at finding defects, validating solutions, and maturing products—faster where it counts. This is possible due to our team's extensive experience in the highly regulated industry, providing you with the expertise and security you need.

Prototype Reviewing

Initial product models are evaluated to identify potential user and manufacturing challenges.

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Prototype Reviewing

Evaluating initial models for challenges

Initial product models are evaluated to identify potential user and manufacturing challenges.

Prototype reviewing is a critical step in the Design for Manufacturing (DFM) phase, where early product models are evaluated for potential manufacturing challenges. The R&D team assesses functionality, manufacturability, and cost-effectiveness to ensure efficient, scalable production while minimizing delays, defects, and cost overruns. This review drives necessary adjustments to align the product with both design and manufacturing requirements.

Troubleshooting

The troubleshooting phase plays a vital role in addressing issues discovered during prototype reviews.

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Troubleshooting

Resolving prototype issues

The troubleshooting phase plays a vital role in addressing issues discovered during prototype reviews.

As part of addressing the issues identified during the prototype review, the troubleshooting phase focuses on resolving the challenges. By proactively addressing potential problems, troubleshooting facilitates smoother production, reduces costs, and improves product quality, ultimately contributing to a more efficient manufacturing process.

Design for Manufacturing (DFM)

At SPT Vilecon, Design for Manufacturing (DFM) is a foundational principle embedded in every phase of the development process. By integrating DFM early, we ensure that each component is optimized for manufacturability, cost-efficiency, and overall quality.

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Design for Manufacturing (DFM)

Streamlining production and enhancing quality through DFM Principles

DFM focuses on key elements such as manufacturing processes, material selection, tolerances, and assembly techniques, all of which play a crucial role in simplifying production workflows. By addressing these aspects from the outset, the design process is streamlined, reducing the likelihood of production challenges, cutting down on costs, and improving the quality of the final product. Additionally, DFM enables the identification of potential issues before they arise, allowing for design refinements that ensure each component is both manufacturable and cost-effective. This proactive approach not only minimizes iterations but also shortens lead times, ultimately driving efficiency and innovation across all stages of product development.

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Design for Assembly (DFA)

Design for Assembly (DFA) plays a crucial role during the Design for Manufacturing (DFM) phase by optimizing product designs to improve the efficiency of the assembly process. By focusing on simplifying and streamlining assembly steps, DFA ensures that products are both cost-effective and high-quality.

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Design for Assembly (DFA)

Enhancing assembly efficiency and reducing costs with DFA principles

By minimizing the number of components, simplifying part handling and orientation, and streamlining assembly procedures, DFA contributes to a significant reduction in assembly time and associated costs. Additionally, it improves the overall quality of the final product by ensuring that each individual component is seamlessly integrated into the assembly process. This approach emphasizes early consideration of assembly factors, leading to a more efficient, cost-effective production cycle and a reduction in the potential for errors. By prioritizing DFA principles, we can achieve a smoother transition from design to production, ensuring both operational efficiency and high-quality outcomes.

Prototype & Test

Prototyping is a vital part of our development process. With in-house injection moulding and particle-monitored test facilities, we assess technical risks, resolve design and manufacturing challenges, and ensure quality from the start. Our full-scale simulation capabilities help partners refine and validate components fast and cost-effectively.

Prototyping within Electronics

We offer a full spectrum of embedded design services tailored to meet the needs of modern electronics prototyping. Our expertise spans embedded systems, advanced circuit design, and seamless integration, ensuring each project delivers optimal performance and functionality.

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Prototyping within Electronics

Embedded systems, circuit design, and seamless integration.

Our embedded design capabilities cover both 8-bit and 32-bit systems, low-power design, and advanced analogue and digital circuit solutions. We also specialize in battery management, digital signal processing (DSP), and IoT design, facilitating smooth integration with data acquisition (DAQ) and cloud data access. We support a variety of communication platforms such as including LTE, Wi-Fi, and Bluetooth Low Energy (BLE), alongside comprehensive PCB design services, from schematic creation to layout. Additionally, we design user-friendly Human-Machine Interfaces (HMIs) with touch displays and provide software development across embedded systems, RTOS, PC, Windows, and mobile platforms. Our services are designed to provide efficient, reliable, and high-quality solutions for diverse applications.

Material Selection

Our material selection process integrates advanced modelling techniques to test material properties and ensure that each choice enhances product performance. We take a comprehensive approach, handling supplier communications and providing tailored recommendations to meet the specific requirements.

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Material Selection

Ensuring durability and functionality through rigorous material evaluation

As part of our material selection process, we employ advanced modelling techniques to rigorously test material properties, ensuring optimal product performance. SPT Vilecon manages supplier relations and material communications, providing expert recommendations tailored to our partners specific requirements. Additionally, we conduct one-of-a-kind quality tests to ensure that all materials meet the highest standards of durability and functionality needed. Our expertise also extends to multi-component moulding and assembly, ensuring that each material is seamlessly integrated into the production process while maintaining exceptional quality across all components.

O-Series / Pre-Production

During the prototype and testing phase, we conduct O-Series production to validate the design and ensure its suitability for mass production. This essential step allows us to evaluate functionality, address potential issues, and verify that the final product meets all performance and quality standards.

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O-Series / Pre-Production

Ensuring product readiness before full-scale manufacturing

O-Series production serves as a critical stage in refining the design before full-scale manufacturing. It provides an opportunity to test the product under real-world conditions, identify any areas for improvement, and confirm that it meets the necessary performance and quality benchmarks. This process is key to delivering a reliable and high-quality end product.

Adjustment, e.g. moulds / Post-0-Series evaluation and refinement

Upon completing the O-Series, we conduct a detailed assessment of the results to ensure the design is fully optimized for production.

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Adjustment, e.g. moulds / Post-0-Series evaluation and refinement

Enhancing design for superior quality and performance

Upon completing the O-Series, we conduct a detailed assessment of the results to ensure the design is fully optimized for production.

After completing the 0-Series, we carefully evaluate the results and make necessary adjustments, such as refining moulds, to ensure optimal product quality and performance. This iterative refinement process ensures the design is thoroughly optimized, addressing any issues before advancing to full-scale production.

First-out-of-tool (FOT)

Following adjustments from the O-Series, we enter the First-Out-Of-Tool (FOT) phase, where the first parts are produced using the (if needed) updated moulds. This stage allows us to validate the design, material, and manufacturing processes in practical conditions.

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First-out-of-tool (FOT)

Confirming design and production readiness

The FOT phase is essential for confirming that all modifications made after the O-Series meets the product specifications. By producing initial parts from the refined moulds, we can assess the design and production methods in real-world conditions, ensuring the final product aligns with performance and quality standards before full-scale manufacturing.

Factory Acceptance Test (FAT)

The Factory Acceptance Test (FAT) is conducted to confirm that the system or machine meets all necessary specifications and performance criteria before leaving SPT Vilecon´s manufacturing facility.

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Factory Acceptance Test (FAT)

Ensuring compliance with specifications and performance standards

The Factory Acceptance Test (FAT) is conducted to confirm that the system or machine meets all necessary specifications and performance criteria before leaving SPT Vilecon´s manufacturing facility.

The FAT is a comprehensive evaluation designed to ensure that the product functions as intended and adheres to all required standards. This critical step verifies that the system is fully prepared for deployment, providing partners with assurance that the final product will perform reliably and meet expectations.

Process validation (validation of manufacturing process and equipment)

Process validation is a crucial element of the prototype and test phase, ensuring that manufacturing processes are reliable and capable of producing high-quality products consistently. This step helps identify potential challenges early and guarantees the final product meets all necessary standards.

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Process validation (validation of manufacturing process and equipment)

Ensuring consistent quality and production efficiency

In the Prototype and test phase, process validation ensures that all manufacturing steps, from assembly to final testing, are performed accurately and efficiently. This includes assessing production workflows, material handling, and the performance of tools and equipment to ensure they align with design specifications. Any issues discovered during this phase are addressed, allowing us to refine processes and eliminate inefficiencies. By confirming that the manufacturing process is robust, we ensure that the transition to full-scale production is smooth, cost-effective, and consistently ensure high-quality products.

Systematic mould commissioning (DoE) (OptiMelt, Mould-Up)

Systematic mould commissioning, guided by the Design of Experiments (DoE) methodology, plays a critical role in the prototype and test phase. This approach ensures that moulds perform optimally, producing consistent and high-quality components.

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Systematic mould commissioning (DoE) (OptiMelt, Mould-Up)

Optimizing mould performance through design of experiments

Systematic mould commissioning using DoE allows detailed analysis and optimization of mould performance. By evaluating key variables such as temperature, pressure, and cycle time, we identify the most effective settings for producing high-quality parts. This structured approach enables precise fine-tuning of the moulding process, addressing potential issues early on. The result is improved mould efficiency, reduced defects, and enhanced consistency in the final product, ensuring all components meet the required specifications before moving to full-scale production.

Stability Assessment

Stability assessment is a key part of the prototype and test phase, focused on evaluating the product's ability to maintain performance and durability over time under various conditions.

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Stability Assessment

Ensuring long-term performance and reliability

Stability assessment is a key part of the prototype and test phase, focused on evaluating the product's ability to maintain performance and durability over time under various conditions.

In this phase, stability assessment tests the product's resilience to factors such as temperature fluctuations, humidity, vibration, and stress. By simulating real-world scenarios, we can identify potential areas of failure or performance issues that may arise over time. This process allows us to make necessary adjustments to improve product longevity and ensure it meets quality standards for extended use. The goal is to confirm that the product will perform reliably throughout its lifecycle, providing confidence in its durability and consistency for end users.

Pilot / Clinical Production

We specialize in turning prototypes into reality through expert pilot production. Our skilled technicians bring years of experience in small-scale manufacturing, assembly, and production start-ups ensuring every component is built with precision, tested for quality, and ready for market validation.

Assembly Processes

The assembly process is essential for transforming individual components into a complete product. It involves a series of coordinated steps to ensure proper integration, functionality, and quality.

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Assembly Processes

Efficient integration of components for high-quality products

The assembly process is essential for transforming individual components into a complete product. It involves a series of coordinated steps to ensure proper integration, functionality, and quality.

During assembly, components are systematically integrated using various techniques such as manual assembly or automated methods. Each step focuses on precise part handling, accurate fitting, and secure joining to ensure the product meets the specifications. Rigorous quality checks are performed at each stage to guarantee performance, reliability, and consistency. The assembly process is designed to be both efficient and effective, delivering high-quality results while minimizing errors and maximizing production efficiency.

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Automatic and manual pilot production

Pilot production leverages both automated and manual methods to create small batches for testing and refinement. This combination ensures flexibility, precise control, and the ability to scale effectively during early production.

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Automatic and manual pilot production

Automation and manual techniques for efficient production

Automated pilot production utilizes advanced machinery and robotics to enhance speed, accuracy, and consistency, making it ideal for repetitive, high-volume tasks. In contrast, manual pilot production offers flexibility, allowing skilled technicians to address complex assembly and make real-time adjustments. This balance of automation and hands-on expertise ensures that each product is produced efficiently while meeting quality standards. By integrating both approaches, we facilitate a smooth transition from prototype to full-scale production.

CE labelling of products and devices

CE labelling is a step in demonstrating that products and devices meet the European Union’s health, safety, and environmental protection standards. This certification ensures that the product is fit for sale and use within the EU market.

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CE labelling of products and devices

Ensuring compliance with european safety and quality standards

The CE marking process involves rigorous testing and documentation to verify that a product complies with all relevant EU directives and regulations. It covers a wide range of industries, including medical devices, electronics, and machinery, requiring manufacturers to meet specific safety and performance standards. Achieving CE labelling involves conducting risk assessments, performing required testing, and maintaining detailed records. Once the product meets all criteria, it is granted the CE mark, which not only ensures legal compliance but also enhances marketability within the EU by instilling confidence in product safety and quality.

Robotics in element release and handling

Robotics plays a vital role in element release and handling, significantly enhancing production efficiency and precision. By automating key tasks, robotics ensures consistent, safe, and high-speed operations, reducing the risk of human error.

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Robotics in element release and handling

Optimizing efficiency and precision in production processes

In element release and handling, robotics systems are used to automate the manipulation and transfer of components throughout the production process. These robotic systems are designed to perform tasks such as picking, placing, sorting, and releasing components with high accuracy and speed. This automation reduces handling time, minimizes product defects, and improves workplace safety by limiting human involvement in potentially hazardous tasks. The integration of robotics also increases overall production throughput, allowing for scalable and cost-efficient operations. With continuous advancements in robotic technology, companies can achieve greater flexibility and precision in handling various elements across industries.

Start-up of small-scale production

The start-up of small-scale production is bridging the gap between prototype development and bigger-scale manufacturing. It allows for the fine-tuning of production processes, ensuring that products meet quality standards before moving to larger volumes.

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Start-up of small-scale production

Streamlining the transition from pilot production to Commercial / Small Scale Production

During small-scale production start-up, initial production runs are conducted to validate processes, identify potential bottlenecks, and refine workflows. This phase focuses on optimizing efficiency, minimizing defects, and ensuring that all system, ranging from equipment to materials, are functioning as intended. By operating at a smaller scale, we can address any issues early, make necessary adjustments, and ensure that the product is ready for larger-scale production. The small-scale start-up phase not only helps in achieving consistent quality but also provides valuable insights that guide the transition to commercial manufacturing.

Commercial / Small Scale Production

We offer flexible pilot production solutions through our in-house facilities, equipped with advanced injection moulding and testing capabilities. Whether producing low-volume batches or preparing for full-scale manufacturing, we support every step with precision and care.

Our experienced team ensures smooth setup, validation, and supplier coordination delivering reliable results either on-site, at our facility, or through trusted outsourcing partners.

Optimizing for full-scale production

Optimizing for full-scale production ensuring that manufacturing processes are efficient, reliable, and capable of meeting higher-volume demands. At SPT Vilecon, we focus on refining every aspect of production to ensure a smooth transition from small-scale runs to large-scale manufacturing.

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Optimizing for full-scale production

Streamlining processes for seamless scaling

As we prepare for full-scale production, our team works closely with partners to assess and optimize key aspects such as production workflows, material handling, and quality control processes. We conduct thorough evaluations and adjustments to ensure that production lines are capable of operating at peak efficiency, reducing waste and minimizing downtime. Our expertise in process optimization, combined with our advanced facilities, enables us to scale production smoothly while maintaining high standards of quality and performance. This focused approach guarantees that the transition to larger volumes is seamless, cost-effective, and aligned with the product's specifications and market needs.

Supplier audit and monitoring

Supplier audits and ongoing monitoring are essential practices for maintaining high standards of quality, performance, and compliance throughout the supply chain. These processes help ensure that suppliers meet specific requirements and adhere to industry regulations.

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Supplier audit and monitoring

A strategic review to validate alignment with our quality, compliance, and performance standards

Conducting thorough supplier audits allows companies to assess the capabilities, processes, and performance of their suppliers before entering into agreements. Regular monitoring ensures that these standards are continuously met, reducing the risk of subpar quality, delays, or non-compliance. Audits evaluate various factors, including production practices, material sourcing, and adherence to safety regulations. By maintaining close oversight, businesses can identify potential issues early, build stronger supplier relationships, and ensure the consistent delivery of high-quality products. This proactive approach also promotes transparency and accountability, fostering a more reliable and efficient supply chain.

Supplier qualification

Supplier qualifications are essential for establishing strong, reliable partnerships that support product quality and timely delivery. By evaluating key factors such as capabilities, certifications, and past performance, businesses can ensure they work with suppliers who meet the necessary standards.

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Supplier qualification

Ensuring reliability and excellence in the supply chain

Qualified suppliers are integral to achieving consistent, high-quality products. The qualification process involves a thorough assessment of a supplier's ability to meet technical, regulatory, and performance requirements. This includes reviewing their production processes, certifications (such as ISO standards), financial stability, and overall reliability. Additionally, past performance is evaluated to determine their capacity to deliver on time and within budget. By setting clear qualification criteria and conducting regular reviews, companies can mitigate risks, enhance supply chain efficiency, and foster long-term, mutually beneficial relationships with trusted suppliers.

Validation

Validation is a critical process for verifying that products, systems, or processes meet the required standard and specifications. It ensures compliance, functionality, and reliability throughout development and production.

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Validation

Compliance and performance across all phases

The validation process involves systematically testing and verifying that products or systems function as intended and comply with regulatory standards. This can include validating designs, materials, production methods, and end-user functionality. Whether it’s through simulation, testing, or audits, validation provides confidence that the final product meets the necessary quality, safety, and performance benchmarks. It also helps identify potential issues early, reducing the risk of costly revisions or compliance failures. By adhering to rigorous validation procedures, businesses can ensure that their products deliver consistent results, satisfy customer expectations, and meet industry regulations.

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Full Scale Production

We bring expertise and precision to full-scale production. By agreement, we take responsibility for specifications, tooling, process setup, and plant installation ensuring a smooth transition from development to manufacturing.

Whether production is launched in-house, on-site, or through trusted outsourcing, we deliver efficient, high-quality solutions tailored to each project.

Standard Operating Procedure (SOP)

A Standard Operating Procedure (SOP) is a vital tool for ensuring that business processes are performed consistently, efficiently, and in compliance with industry standards. SOPs help streamline operations, reduce errors, and maintain high-quality outcomes.

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Standard Operating Procedure (SOP)

Establishing consistency and quality in operations

Standard Operating Procedures provide clear, step-by-step instructions for performing routine tasks, ensuring uniformity across teams and departments. These procedures help mitigate the risk of mistakes, enhance operational efficiency, and ensure that activities are aligned with regulatory and safety requirements. By documenting best practices and creating standardized guidelines, SOPs make it easier for employees to understand expectations and perform tasks effectively. Regularly reviewing and updating SOPs ensures that they remain relevant and reflect any changes in processes, technologies, or compliance requirements, fostering continuous improvement and operational excellence.

Packing instructions, etc.

Packing instructions are crucial for guiding the proper handling, packaging, and shipping of products to ensure their protection and integrity during transport. These instructions provide clear guidelines on how to prepare products for delivery while minimizing risks of damage or contamination.

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Packing instructions, etc.

Secure and efficient packaging for safe delivery

Our packing instructions service covers everything from material selection to packaging design, ensuring the products are protected throughout the shipping process. We offer customized solutions for fragile, sensitive, or bulk items, considering factors like size, weight, and handling requirements. With clear and precise packing instructions, we ensure that your products arrive at their destination in optimal condition, while also optimizing shipping efficiency and cost-effectiveness. This service provides peace of mind, knowing that your products are properly prepared for transport, minimizing risks and delays.

Customer’s Quality Management

At SPT Vilecon, we align with our partners' quality management systems to ensure that every product and service meets the highest standards of quality, performance, and compliance. We work closely with our partners to understand their specific quality requirements and integrate them into every phase of the production process.

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Customer’s Quality Management

Ensuring excellence and consistency across deliverables

Our approach to quality management is built on collaboration and precision. By understanding and adhering to the partner’s established quality protocols, we ensure that all processes - from design and development to production and delivery - are optimized to meet or exceed expectations. We incorporate thorough inspections, testing, and validation at each stage, guaranteeing that the final product meets regulatory standards and performs reliably. By consistently monitoring and refining our practices, we help customers maintain product integrity, enhance customer satisfaction, and minimize risks associated with quality defects.

Preparation for full-scale

Preparing for full-scale in scaling up operations are ensuring efficient, high-quality manufacturing. This step involves refining processes, optimizing workflows, and making the necessary adjustments to handle larger volumes while maintaining product consistency.

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Preparation for full-scale

A smooth transition from prototype to mass manufacturing

The preparation for full-scale production involves thorough planning and testing to identify potential bottlenecks, ensure supply chain readiness, and confirm that all systems are equipped to handle increased production volumes. During this phase, we fine-tune manufacturing processes, update equipment as needed, and validate that every aspect of production is optimized for efficiency and quality. Our team works closely with customers to align on timelines, materials, and resources, ensuring that the transition to full-scale production is seamless and cost-effective. With careful preparation, we are able to meet demand, deliver on time, and maintain the highest quality standards throughout the production lifecycle.

Purchase raw materials

Purchasing raw materials is a critical component of ensuring that production runs smoothly and efficiently. At SPT Vilecon, we focus on sourcing high-quality materials that meet our stringent standards, enabling us to deliver products that exceed customer expectations.

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Purchase raw materials

Sourcing quality materials for efficient production

Our procurement process involves thorough research and careful selection of suppliers who can deliver consistent, high-quality raw materials at competitive prices. We prioritize materials that align with our customers' specific requirements, whether for durability, performance, or compliance with industry regulations. By fostering strong relationships with trusted suppliers, we ensure a reliable supply chain that supports uninterrupted production. Regular quality assessments and compliance checks are carried out to guarantee that all materials meet our exacting standards, minimizing risks and enhancing the overall efficiency of the manufacturing process.

Components, etc.

Components are the building blocks of any product, and ensuring their quality, functionality, and compatibility is crucial for the overall success of the final assembly. At SPT Vilecon, we focus on sourcing, testing, and integrating components that meet rigorous standards of excellence.

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Components, etc.

Ensuring quality and precision in every part

We carefully select and source components based on their performance, durability, and suitability for each project. We work closely with suppliers to ensure that every part is manufactured to precise specifications and tested for quality. Each component undergoes rigorous inspection, ensuring that it meets all necessary regulatory standards and integrates seamlessly into the final product. By prioritizing high-quality components, we help ensure that the end product is reliable, efficient, and ready for the market, reducing the risk of defects and enhancing overall product performance.

Supplier Agreements

Supplier agreements are essential for establishing clear expectations and fostering long-term, mutually beneficial relationships between businesses and their suppliers. At SPT Vilecon, we prioritize creating transparent, effective agreements that ensure the timely delivery of high-quality materials and components.

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Supplier Agreements

Building strong partnerships for reliable supply chains

A well structured supplier agreement outlines critical terms such as pricing, delivery schedules, quality standards, and compliance requirements, ensuring both parties are aligned on expectations. By formalizing these terms, we mitigate risks associated with supply chain disruptions, product defects, and non-compliance. Our agreements are designed to promote clear communication, timely responses, and accountability, fostering strong, collaborative partnerships with our suppliers. This approach helps us maintain a reliable supply chain, reduce costs, and meet production deadlines while upholding the highest quality standards for every product.

Tools and equipment compatibility

The compatibility of tools and equipment is critical for maintaining efficiency and achieving consistent product quality in the manufacturing process. At SPT Vilecon, we focus on selecting and integrating tools and equipment that align perfectly with your production needs and systems.

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Tools and equipment compatibility

Integration for optimal performance

To ensure smooth operations and prevent delays, we prioritize the selection of tools and equipment that are compatible with existing production systems and processes. This involves assessing various factors, such as material compatibility, system integration, and performance requirements. Our team works closely with clients to evaluate their specific needs, ensuring that every piece of equipment works cohesively with other components of the production line. By focusing on compatibility, we enhance operational efficiency, reduce the risk of downtime, and ensure high-quality outputs throughout the production cycle. This approach ensures that your manufacturing process runs smoothly, reliably, and cost-effectively.

Outsourcing

Outsourcing can be a powerful way to boost efficiency, flexibility, and speed to market. Whether driven by capacity, cost, or specialized expertise, we help partners focus on their core strengths while maintaining top-tier production standards.

With a trusted network across Denmark and abroad, we offer tailored outsourcing solutions and can manage the entire process from supplier coordination to full implementation within your quality system. The result is smooth execution, consistent quality, and delivery on time and to specification.

Strategic Outsourcing for Smarter Growth

Through strategic outsourcing, our partners gain the flexibility and expertise needed to meet changing market demands and we provide the specific knowledge in-house to help them navigate in a strategic direction.

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Strategic Outsourcing for Smarter Growth

In today’s fast-evolving healthcare landscape, adaptability is key.

Our partners often explore outsourcing in areas that are complex, resource intensive, or require deep specialization. As demand increases and they're ready to grow, we help guide them toward trusted experts who can deliver reliable, high-quality support at scale. For instance, outsourcing clinical trials and research enables companies to manage complex testing protocols more efficiently and accelerate time to market for new products. Packaging and labelling services ensure global compliance is met with precision and consistency, while supply chain and distribution solutions offer the scalability and control needed as operations expand. Regulatory compliance and quality assurance are also frequently outsourced to maintain strict alignment with FDA and international standards. In the digital realm, many companies turn to software development partners to create secure, connected medical devices and platforms. Legal and intellectual property services are similarly handled externally to protect innovations and simplify licensing. These are just a few examples of how strategic outsourcing can drive efficiency, reduce costs, and support long-term, sustainable growth.