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.
Learn more about The Value Wheel.
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.
0-series production
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)
Document control
FAT/SAT– from injection moulds and automation equipment to complete production units
Lean/Six Sigma projects
Metrological tasks
NC-SCAR – Non Conformity/Supplier Corrective Active Report
Process development
Process stability
Product development
Productivity optimisation
Quality assurance
Quality control
Quality management
Risk management
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