From farming to teaching to firefighting, there are many principles of non-medtech professions that can be applied to EU MDR implementation.
Post-market requirements outlined in the regulation carry significant process challenges and procedure updates. Start simple and try not to overcomplicate your processes.
When outsourcing these key functions, asking the right questions will help minimize the risk.
An explanation of these principles and the actions that must be addressed in compliance with 21 CFR 820, ISO 13485 and the EU MDR.
With the heightened supplier scrutiny, it’s time to reevaluate your supplier quality program.
Think outside of the box and approach your QMS with passion and creativity.