Date/TimeDate(s) - June 27, 2023
09:00 AM - 03:45 PM CET
Date: 27 June 2023
Location: Virtual Training
Time: 9:00 am – 3:45 pm Central European Time (EU)
Pricing: Early Registration through 13 May 2023: $500 USD
Regular Registration beginning 14 May 2023: $600 USD
The chemical and physical characterization of materials and devices has long been considered an important step in evaluating biological safety. The most recent revisions of ISO 10993-1:2018 and ISO 10993-18:2020 continue to emphasize the importance of this evaluation and potential testing needs.
There are several potential nuances medical device manufacturers must understand when applying ISO 10993-18: 2020. For example, Notified Bodies may require additional evaluation to meet the requirements of the EU’s Medical Device Regulation (MDR), while the U.S. Food & Drug Administration (FDA) has placed an increased emphasis on characterization and requests very specific requirements as outlined in the 2016 guidance document (while continuing to expand the use of the analytical data). The successful implementation of this standard, and evaluation outlined in supporting documents, is critical for medical device manufacturers if they wish to stay on track with market clearance plans.
In this session, NAMSA will discuss the chemical characterization of materials and the evaluation steps to choose proper tests, extracts and test durations to meet the latest industry requirements. This workshop will include instruction and multiple hands-on exercises guided by an experienced NAMSA instructor.
Upon completion, attendees will be able to:
- Relate ISO 10993-18:2020 to ISO 10993-1:2018 and the biological evaluation of devices
- Discuss the changes in ISO 10993-18:2020 in a practical use format
- Discuss how material and chemical characterization fit into the MDR
- Develop a testing strategy for multiple devices
- Plan for future testing needs of materials and finished medical device
- Solve problems that may occur during testing, such as a degraded sample or liquid test articles
Who Should Attend?
- Regulatory Affairs and Quality Assurance Professionals
- Research, Design and Manufacturing Engineers
- Microbiologists and Chemists involved in the evaluation of Medical Devices
- Product Managers, Laboratory Managers
- Process Development and System Engineers
- Toxicologists and Biological Safety Specialists
- Testing professionals that require continuing education for RAPS Certification
- Attendees of NAMSA Course A or B and desire more hands-on experience with chemical characterization
NOTE: If you are working from home during this time, please ensure to include your home address under the shipping field during registration. Course materials will be shipped to the shipping address you provide.
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Alfred Dibao-Dina, Ph.DBiological Safety Scientist
Alfred Dibao-Dina holds a Ph.D. degree in Biomedical Engineering. At NAMSA since 2017, he started as a Technical Advisor by providing technical and regulatory guidance to medical device’s manufacturers through preparation of quotes for consulting and testing services compliant with the international standards. His current role at NAMSA as a Biological Safety Scientist focuses on the redaction of Toxicological Risk Assessments per ISO 10993-17 and Biological Risk Assessments per ISO 10993-1 and ISO 14971. He is knowledgeable in evaluating the biocompatibility of medical devices according to the ISO 10993 series and provides regular internal and external trainings in chemical characterization according to ISO 10993:18.