Standards Compliance

Biological Safety and Biocompatibility of Medical Devices ›

Biological safety and biocompatibility are crucial aspects of medical device development, ensuring that devices do not cause harm to patients or users when in contact with the body. Demonstrating biocompatibility is essential for regulatory approval and market access, as it involves assessing the device’s interaction with biological systems and verifying its safety through comprehensive testing.

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
Metehan Agaca
Senior RA Manager

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Metehan Agaca
Senior RA Manager

Let's Connect

Talk to an expert