We offer expertise and consultancy services within concept, design, development and construction of medical devices, manufacturing, metrology/test methods/analyses, QA (Quality Assurance) and RA (Regulatory Affairs).
We have a thorough and structured approach to every project – which is always based specifically on The Value Wheel and the customer’s specific needs.
The projects we work with vary in value from tens of thousands to 900 million Danish Kroner (from EUR 1,000 to 120 million). No matter the size of the project, we apply unimpeachable standards of integrity and professionalism.
The Value Wheel symbolises our approach to project management. Every project is steered professionally through each phase – 360°. We focus consistently on quality, goals, rapid implementation and on creating durable solutions.
We offer our customers a tailor-made package of consultancy services. We typically assign our consultants to a customer for a designated period, during which they resolve the task in cooperation with the customer’s team and organisation.
Analyses and test methods
CE labelling and 510 (k) approvals
Concept and design of elements and devices
Construction of plastic elements and complete devices
Design for Manufacturing (DFM)
FAT/SAT– from injection moulds and automation equipment to complete production units
Lean/Six Sigma projects
NC-SCAR – Non Conformity/Supplier Corrective Active Report
Supplier management, surveillance and evaluation
Testing injection mould capability
Testing injection moulds/troubleshooting and optimisation
Troubleshooting injection moulds and processes
Usability engineering / risk assessment
Validation of components/devices and manufacturing equipment