With a team of medical device professionals spanning decades of industry experience, Distinct Compliance Engineering can assist you with your medical devices, including active and IVD, within all classes to local and international requirements.
Areas we can help you include;
- ISO13485 Quality Systems implementation, management and consulting
- 1st and 2nd party audits
- 3rd party audit representation
- IEC62366 Usability Engineering Development.
- ISO62304 Software Development Lifecycle methodologies and implementation.
- ISO14971 Risk management consulting and implementation.
- IEC60601 Guidance (general, collateral, and particular standards).
- Test protocols and other technical documentation.
- Clinical evaluation consulting.
- Validation/verification development and consulting (process/equipment/product).
- Jigs and fixtures design and manufacture.
- Medical Device Directive consulting.