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 BEP meet the specific requirements of your device, streamlining the path to regulatory approval.
In vitro biocompatibility testing
We perform in vitro biocompatibility testing to address the three key safety endpoints for all medical devices:
Biological Evaluation Report (BER)
Our experts provide in-depth evaluation of test results, including toxicological risk assessments and the preparation of BER for regulatory submissions.
Explore our integrated testing and advisory services
Relevant regulations and standards:
ISO 10993 standard series;
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
