We support your biological evaluation.

Ensuring biological safety of your Medical Devices

Biological evaluation is a crutial for any medical device that comes into contact with patients. It assesses potential risks related to biological safety and requires a deep understanding of toxicology, pharmacology, and regulatory standards.

With over 25 years of experience, SenzaGen’s group companies offer personalized, expert guidance to help you plan, analyse, test, and document your entire biological evaluation process.

GAP analysis and Biological Evaluation Plan (BEP)

We conduct comprehensive GAP analysis of your devices, identifying potential biological safety risks full compliance with ISO 10993 standards.

Our custom-designed Biological Evaluation Plans (BEPs) meet the specific requirements of your device, streamlining the path to regulatory approval.

In vitro biocompatibility testing

As part of the biological evaluation, we perform in vitro biocompatibility testing to address the three key safety endpoints for all medical devices:

Biological Evaluation Reports (BER)

Our experts provide in-depth evaluation of test results, including toxicological risk assessments and the preparation of Biological Evaluation Reports (BER) for regulatory submissions.

Relevant regulations and standards:

ISO 10993 standard series; Biological evaluation of medical devices

US FDA guidance document on ISO 10993-1 (2020)

ISO 14971:2019 Medical devices – Application of risk management to medical devices

The EU Medical Device Regulation (MDR) 2017/745

OECD TG 428 skin absorption: in vitro method