- Does your Design documentation respect FDA requirements?
- Is traceability between user needs and validation process maintained?
- Is the whole documentation of your product development and validation compliant with the regulation?
- Is your Software Development process in compliance with IEC 62304?
- Are your Design Changes documented as expected?
- Is your Corrective Action and Preventive Action (CAPA) process in accordance with the regulation?
- How to handle risk management according to ISO 14971.
- How to analyse a software risk.
- Is your Risk Management File (RMF) in accordance with regulation?
- Is your RMF correctly interfaced with your usability file (respectful of IEC 62366)?
- Does your product qualify as medical device?
- Which european directive should be applied?
- What class does your medical device belong to?