START 5 Webinar

The live webinar focuses on the latest aspects of biocompatibility and ethylene oxide sterilization (EO/EtO) requirements. It is suitable for people responsible for the quality, regulatory, R&D, vigilance, clinical evaluation, and management of medical device manufacturers.

 The live webinar is for all, who want to find state-of-the-art approaches and requirements, and most important: how to handle them!


The biocompatibility part which takes 2h, will answer the following questions:

  • What are the requirements of MDR, ISO 10993, Notified Bodies and Competent Authorities?

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

  • How to prepare samples for testing? How many samples are needed? How do I need to be prepared?

  •  What is the role of ISO 17025 and GLP?

  • Which tests are needed for my medical device?

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

  •  How to plan extraction strategy and solvent selection?

  • What is the role of Analytical Evaluation Threshold (AET) calculation and analytical uncertainty factor?

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

  • How long does biocompatibility testing take?

  • Which changes in medical devices require additional testing?

  • A new standard revision – do I need to test my product again?

  •  What are the biocompatibility testing requirements in various countries?

The EO sterilization part which takes 1h, will answer the following questions:

  • What basic knowledge of microbiology is necessary for you?

  •  What are the advantages and disadvantages of EO sterilization?

  • What is the flow of a typical EO sterilization process?

  • What is the influence of critical parameters on the effectiveness of EO sterilization process

  • How to validate EO sterilization process?

  • How to calculate D-value?

  • How to create appropriate PCDs?

  • How to determine half-cycle dwell time?

  • How to determine residuals level?

  • What challenges can you expect during EO process validation?

Webinar price is 100 € (the price does not include VAT tax)

Dr. Łukasz Szymański

  • Ph.D. in medical sciences
  • 35 publications in scientific journals with an impact factor
  • Principal investigator or co-investigator in >10 scientific projects
  • Head, principal investigator, or co-investigator in >10 R&D projects
  • Evidence-based Toxicology, Johns Hopkins University
  • Polish Society of Toxicology member
  • Principle GLP Investigator
  • OECD Expert Group member in immunotoxicology
  • Certified Internal Auditor ISO 19011
  • Notified Body Technical Expert

Dr. Damian Matak

  • Ph.D. in medical sciences, M.Sc. and Eng. in biotechnology, postgraduate degrees in management, clinical trials, evidence-based toxicology
  • Member of Polish Society of Toxicology, I Local Ethical Committee
  • Expert of OECD Group in immunotoxicology, Foundation for Polish Science, National Centre for Research and Development, Medical Research Agency
  • Author or co-author of >15 scientific articles and book chapters
  • Recipient of >10 scientific awards
  • Inventor of III-class medical devices, experienced in the certification process
  • CEO of ISO 17025-accredited, and GLP-certified laboratories specialized in comprehensive medical device testing: chemistry, biocompatibility, microbiology & sterility, reprocessing validation, packaging validation, and aging

Dr. Andrzej Decewicz

  • Medical degree, Specialty – gynecology, obstetrics, cytology, ultrasonography
  • 10+ Years of medical practice
  • 30+ Years of medical industry practice including sterilization and validation
  • Experienced in clinical evaluation and risk management
  • Experienced in the validation of EO sterilization process
  • Experienced in the design and development of medical devices
  • Inventor of 14 patented medical devices or improvements
  • CEO of medical devices manufacturer