Webinar

START 5 Webinar

The live webinar focuses on the latest requirements of biocompatibility for medical devices and will answer the following questions:

  • What are the latest FDA requirements?

  • Biological Evaluation Plan (BEP), Biological Evaluation Report/Biological Risk Assessment (BER/BRA) – how to waive some testing using it?

  • ISO 10993-18:2020 chemical characterization (extractables &leachables) – how to handle that?

  •  Toxicological evaluation ISO 10993-17:2023 – is it always necessary?

The webinar will take about 1hr 30min, plus an additional 30min for Q&A,

 

The webinar is free of charge

    The webinar will start on Wednesday MAY 29 TH - 10AM PT/ 1PM ET.

    Register for the webinar:



    Dr. Lukasz Szymanski

    DSc: Chief Scientific Officer (CSO) at NABI

    • 🌎 Throughout his career, Lukasz has held key roles such as deputy head of the Department of Microwave Safety and head of the Interdepartmental GLP Laboratory. He has also pursued fellowships at prestigious institutions including the Institute of Genetics and Development in Rennes, France, and the Translational Vectorology, Vector and Genome Engineering Facility at the Children’s Medical Research Institute in Sydney, Australia.
    • Apart from his enormous contribution to scientific excellence at NABI, he also serves as the CSO at the European Biomedical Institute (EBI), being a part of Biomedical Institutes Group together with NABI. He also holds the position of Assistant Professor at the Institute of Genetics and Animal Biotechnology of the Polish Academy of Sciences.
    • 🎓Interesting fact: Lukasz earned his Ph.D. in medical sciences at an early age of 25.

    Dr. Damian Matak

    President at NABI – North American Biomedical Institute

    • Damian brings a wealth of expertise to his role, serving as the CEO of ISO 17025-accredited and GLP-certified laboratories, including NABI – North American Biomedical Institute and EBI – European Biomedical Institute.
    • 🎓With a Ph.D. in medical sciences, M.Sc. and Eng. degrees in biotechnology, Damian’s educational background includes postgraduate studies in management, clinical trials, and evidence-based toxicology. Recognized as an immunotoxicology expert by the OECD Group, he contributes significantly to organizations like the Foundation for Polish Science, the National Centre for Research and Development, and the Medical Research Agency. Additionally, Damian plays a pivotal role in assisting manufacturers in developing new devices and bringing them to the market. With over 10 scientific awards to his name, Damian’s commitment to excellence shines through.
    • Outside of work, he’s an avid enthusiast of the automotive world, particularly 🏍️motorcycles, and has a keen interest in the investment realm. Damian is also an active member of the 🦮Dogo Argentino owners community, where he organizes meet-ups and training sessions across Poland, proudly owning a beloved Dogo Argentino named Hector