Our engineers have several years of experience working with development of new medical devices as well as sustaining activities for existing medical devices on the market. They excel at project management involving everything from simpler changes on existing products to large development projects for new medical devices. We have extensive experience from the past two years of working with Medical Device Regulation and getting existing medical devices updated and approved per the new EU regulation.
Experience from Design Control documentation and activities such as:
- Risk management
- Requirement management
- Anomaly/defect management and change management
- Test protocols and reports
- Creation and validation of labelling
- Design Reviews
Especially skillful in Design Transfer activities:
- Experience from manufacturing as well as how to move from development into manufacturing
- Design for manufacturability
- Development of MFG instructions
- Development of process controls and release tests
- Establishment of Device Master Record