We supports you in your efforts to comply regulatory requirements of the EU, Canada and the US; and to bring your medical device on the market.
This can be
- MDR + Article 15 (PRRC – ‘Person Responsible for Regulatory Compliance’)
- IVDR + Article 15 (PRRC – ‘Person Responsible for Regulatory Compliance’)
- Clinical evaluation + PMCF
- PMS / Vigilance processes
- AU Authorized Representative + FSC (Free Sales Certificate)
- Quality Management System (ISO 13485)
Please contact us for more information.