Our Services

The list below is not exhaustive. All questions will be studied.​

Document Review

  • 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?
Make sure to have an external eye organize a complete review of your documentation, in order to anticipate audits or optimize submission files.

Process Review

  • 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?

Risk Management

  • 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)?

Regulatory Review

  • Does your product qualify as medical device?
  • Which european directive should be applied?
  • What class does your medical device belong to?