Standards Compliance for Your Medical Device
The regulatory environment for medical devices includes international standards developed by the medical device community. These standards represent collective knowledge on achieving quality assurance for medical devices. Adherence to these standards is often a good start to demonstrating compliance with corresponding regulatory requirements. Furthermore, correctly understanding, interpreting, and using these standards is crucial for bringing a safe and effective medical device to market.
What can we do for you?
Our medical device team has extensive experience and expertise to support you with:
- Review of Biological safety and biocompatibility of medical devices
- Review of Usability analysis according to ISO 62366
- GSPR Verification for Medical Devices