Advanced Biocompatibility: How to Comply with The New Requirements in ISO 10993 Series in a Simple Way and According to MDR
The recent release of ISO 10993-1:2018 and the upcoming Medical Device Regulation (MDR) General Safety and Performance Requirements (GSPR) bring new challenges for medical device manufacturers
The recent release of ISO 10993-1:2018 and the upcoming Medical Device Regulation (MDR) General Safety and Performance Requirements (GSPR) bring new challenges for medical device manufacturers.
This course is structured to be hands-on and is designed for those who have a working knowledge of biocompatibility and are looking to update and sharpen their skills, in light of new updates and developments.
Led by a trainer with substantial experience in biocompatibility, chemical characterization and sterilization validation, the course will also be augmented with a Q&A session (via teleconference) from a certified toxicologist, as well as case studies provided both by the trainers and by notable Danish medical device manufacturers.
Topics covered in this course:
- Impact of the updated ISO 10993-1 (2018) for all types of devices (Class I, II, III, including transient skin contact). How should an appropriate biological risk assessment be prepared, including rationales for a reduced testing program.
- Biocompatibility under MDR: Is ISO 10993 sufficient to effectively claim GSPR compliance?
- ISO 10993-18 (2020): A detailed look at this recently updated standard via practical workshops to choose proper tests, extracts and test duration. The workshops will include class led instruction, as well as multiple hands-on exercises for attendees to learn while being guided by an experienced instructor.
- ISO 10993-17 and ISO TS 21726 (2019): Understanding how to perform toxicological risk assessments using TTCs
- ISO 10993-7: EO Sterilization residuals, overview of the standard and current state of the art
- Upcoming revisions of ISO 10993-12, ISO 10993-9, ISO 10993-7: what can we expect?
This course is targeted at but not limited to:
- Biosafety specialists
- Biocompatibility specialists
- Material specialists
- Risk managers
- Regulatory specialists and managers
- Product design engineers
- Clinical affair specialists and managers
- Quality assurance specialists and managers
The course is at advanced level therefore it is recommended that participants have in-depth knowledge of the ISO 10993 Series.
Don Pohl, Principal Product Development Strategist
Valeriane Levelut, Toxicologist, NAMSA
Joe Brinkman, Senior Technical Advisor, NAMSA