Regulatory Compliance

ISO 13485 - Quality | ISO 14971 - Risk | IEC 60601 - Technical | IEC 62366 - Usability | IEC 62304 - Software

US FDA | EU CE | UKCA

Medical Device Documentation

Whether you are looking for someone to review your existing documentation or help you write in the format that regulatory bodies expect, we would love to work with you!

Common Documentation Templates
  • Design inputs - User needs, Requirements

  • Risk Management - Plan, FMEAs

  • Design outputs - Test protocols, Reports

  • Process - Quality, Manufacturing, Post-market surveillance

Have any questions?

If you have any questions about the therapies, feel free to contact us.