Active Medical Devices

At MD Project we have more than 25 years of experience with a broad range of active medical devices. Our experience ranges from development, production, repair and maintenance of active medical devices up till QA and RA support. In addition we have conducted many internal and supplier audits and technical file reviews at active medical device companies.

Therefore, for active medical devices in general we can support you with a broad scope of activities e.g.:

– Classification of active medical devices
– Set up of regulatory approval strategy and action plan
– Selecting and accompanying project related visit at test labs for performing electrical safety and / or EMC tests, review of test plans and reports
– Assistance in selecting subcontractors for assembly or sub-assembly of your products including subcontractor audits for compliance verification
– Setting up of a technical file for regulatory compliance based on STED format
– Support of the risk management process and design review stages
– Support in “software related” regulatory compliance activities