The main scope of ISO 10993 is to protect patients from biological risks arising from the use of medical devices. The standard states that the biological evaluation of a medical device (or a material component of such) should be conducted within the framework of a risk management process. Such a process should generally begin with assessment of the device, including the material components, the manufacturing processes, the clinical use of the device including the intended anatomical location, and the frequency and duration of exposure.
Considering this information, the potential risks from a biocompatibility perspective should be identified. Such risks might include chemical toxicity, unacceptable biological response to physical characteristics of the device, and aspects of manufacturing and processing that could alter the physicochemical characteristics of the device, which could lead to changes in the biocompatibility response. The data coming from the chemical characterization should be toxicologically assessed to elucidate the need for further tests to address the relevant biological endpoints for the device under evaluation.
This Conference will provide a wide and comprehensive overview of critical aspects and latest updates on ISO 10993 and the impact that these upcoming changes will reflect on the medical devices industry.
WHO SHOULD ATTEND
This Conference offers a rewarding experience and is particularly relevant to both specialist or beginner within biocompatibility, product safety, material specialist, material characterization, R&D, production, process development or Quality Assurance/Regulatory Affairs.
- 9.00 – 9.30: Introduction and general overview (Ayelet Geva)
- 9.30 – 10.15: ISO 10993 standard series: approaching biocompatibility within a risk management process (Paolo Pescio)
- 10.15 – 10.45: Introduction to the new FDA guidance (Orly Shenkar – Sally Bercovich)
- 10.45 – 11.00: Coffee break
- 11.00 – 11.45: Chemical characterization of the materials: what does it means in practice (Paolo Pescio)
- 11.45 – 12.15: Toxicological assessment (ISO 10993-17) application in order to evaluate obtained data from chemical chemical characterization (Paolo Pescio)
- 12.15 – 13.00: Bridge approach and change management optimization thanks to chemical characterization (Paolo Pescio)
- 13.00 – 14.00: Lunch break
- 14.00 – 15.30: Biocompatibility tests overview: In vivo tests In vitro tests (Paolo Pescio)
- 15.30 – 16.00: What’s new in ISO Technical Committee 194 “Biological and clinical evaluation of medical devices”: an update from October 2017 meeting in Seoul (Paolo Pescio)
- 16.00 – 18.00: One on One meetings
With more than 10 years of experience performing pre-clinical evaluation for medical devices earned a M.S. in Biomedical Engineering from Polytechnic University of Milan (Italy). Former
Chairman of the UNI U4201 Committee for non-active medical devices for transfusion and biological evaluation is an active member of ISO TC194 and CEN TC206 groups. He also has a successful background as Test Facility Manager, and his expertise lies in: Toxicological evaluation and risk assessment Biological evaluation of medical devices Integrated Testing Strategies Validation of sterilization process E&L assessment PDE evaluation.
Ayelet’s background stems from the High Tech industry where she was a product owner and a consultant for entrepreneurs and startups of different sizes. She has more than 16 years of managerial experience. Ayelet has a proven business insight, vast software development experience, managerial and communication skills alongside an in-depth experience facing clients and anaging large scale products of both in Israel (Motorola, SintecMedia, BioGaming etc.) and Internationaly (TEVA, FOX, ESPN CTV etc.). Ayelet’s current position is Li-Med CEO.
Orly’s is a QA/RA expert with a BSC & MSC in Biotechnology and more than 7 years of experiance. Her professional path in the QA\RA world started in Direx and Biocontrol medical, where she anaged the QA engineering team. Orly has a strong professional background and solid managerial skills which allows her to manage regulatory projects and quality assurance for companies in the field of medical device.
Sally is QA\RA expert with vast experience in leading quality processes and regulatory projects for companies in the field of medical devices and agriculture. Her main expertise is sterilization validation and biocompatibility. She holds a BSC in life sciences and MSC in Biotechnology. Sally’s strongest suit is her broad understanding of processes and her ability to drill down to the smallest detail.