Date(s) - 02/28/2019
1:00 pm - 5:00 pm JST
Nihonbashi Life Science HUB
This is a Sold Out event.
NAMSA’s Biocompatibility Summit program* brings thought leadership and industry professionals to you. This complimentary, intimate gathering allows for expert discussions and shared experiences in medical device development and biocompatibility. Ultimately, you will leave the summit with recommendations, updates, guidance and resources critical to your device development process, as well as tools to help you on the path to becoming the expert.
(*Program will begin at 13:00 JST.)
Topics to Be Covered
I. ISO 10993-1 2018 Updates: What are the Relevant Changes & How They Impact the Biocompatibility Safety Evaluation Process for Medical Device Manufacturers?
Since 2009, the emphasis on a risk management process and characterization of materials continues to shift the biological safety paradigm. In today’s world, there is continued interest in how an evaluation is conducted long before any biological tests are performed. In addition, with the release of ISO 10993-1:2018 in August 2018, there is a continued focus in biological safety planning and implementation processes, as well as the characterization of materials. Once again, medical device manufacturers are being asked to go beyond the simple process of identifying a set list of biocompatibility tests when evaluating a device’s biological safety. Join us for this session to learn how manufacturers can efficaciously prepare for implementation of these new requirements.
II. EU MDR: GSPR for the Biocompatibility of Medical Devices
This session will provide information on the technical documentation required under the EU’s Medical Device Regulation (MDR) General Safety and Performance Requirements (GSPR). Provided will be best practices and meaningful tips for manufacturers with devices sold under CE marks and will an explanation of how these requirements supersede current EU Medical Device Directive (MDD) 93/42 and 2007/47 as they relate to Biocompatibility throughout the full medical device lifecycle.
Who Should Attend?
- Clinical Affairs Specialist, Manager or Director
- Product Development
- Research & Development
- Regulatory Affairs Specialist, Managers, Director
- Quality Assurance Specialist, Managers, or Director
- Clinical Operations
- Clinical Project Management
- Sterilization Specialists
- Sterility Assurance Managers
- Validation Engineers
- Packaging Engineers
- Design Engineers