Date(s) - 02/05/2019 - 02/07/2019
Anaheim Convention Center
NAMSA invites you to meet with us at the upcoming MD&M West Conference, North America’s largest annual medtech show on February 5-7, 2019, in Anaheim, Calif. This unique event connects medical device organizations with thousands of advanced design and manufacturing professionals for three days of industry immersion. Provided will be learning and networking opportunities discussing current medtech challenges and the latest innovations reshaping the industry.
Special NAMSA Half-Day Workshop: Biological Safety & Global Regulatory Requirements
Join NAMSA’s laboratory testing and regulatory strategy experts for a special half-day workshop on Tuesday, February 5, to learn critical components of biological safety and how they relate to specific global regulatory requirements.
8:30-9:10 AM: ISO 10993-1 2018 Updates: What are the Relevant Changes & How They Impact the Biocompatibility Safety Evaluation Process for Medical Device Manufacturers (Presented by Don Pohl, Manager of Biological Safety and Validation)
Description: 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. And, 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.
9:10-9:50 AM: Global Regulatory Requirements for Chemical Characterization: How to Cost-Effectively Demonstrate Biological Safety (Presented by: Dr Phillip Smiraldo, Medical Research Scientist)
Description: Medical device organizations that manufacture products that involve patient contact are most often required to perform some level of chemical characterization evaluation, per ISO 10993-18, to ensure end-user safety. Depending on a device’s intended clinical use, chemical characterization – specifically, extractable/leachable testing – may be required by various regulatory agencies to address biological safety. However, utilizing this type of testing methodology to address various updates to medical devices can prove to be a cost-effective way to assess device changes and their potential impacts to biological safety. This session will highlight global regulatory requirements for chemical characterization testing and discuss how manufacturers can use chemical characterization to demonstrate biological safety for their devices.
9:50-10:30 AM: EU MDR: Are you Prepared? GSPR of the EU MDR for the Biocompatibility of Medical Devices (Presented by: Don Pohl)
Description: This session will provide information on the technical documentation required under the EU’s 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 MDD 93/42 and 2007/47 as they relate to Biocompatibility throughout the full medical device lifecycle.
10:45-11:15 AM: “New” Testing Methodologies to Minimize Degradation and Maximize Extractable Compounds: Getting the Most out of your UPLC-MS (Presented by: Angela Sanchez, Principal Chemist)
Description: NAMSA is developing new methodologies to identify and utilize the best extraction vehicles to maximize relevant extractable compounds while minimizing degradation. This method, providing extracts compatible with analytical instruments (leaving the polymer structure unchanged), will be discussed as well instrument-specific methods for Ultra-Performance Liquid Chromatography-Mass Spectrometry (UPLC-MS)—today’s tool of choice for the detection of nonvolatile compounds to confirm molecular weight and structure identification.
11:15-11:45 AM: Ask the Experts: Speaker Panel Discussion and Q&A
For additional details on the sessions above, including full descriptions, please visit the MD&M West website here.
NAMSA’s medical device development experts will be available throughout the conference for complimentary consultations. We welcome the opportunity to discuss the most efficient and cost-effective pathways to market based on your unique product development requirements.
We’ll even walk you through our latest success story, which discusses the significant milestones that NAMSA achieved in partnership with Dental manufacturer, Solvay Dental 360, including information on how the organization saved $7.5M and 12 months in 510(k) development costs.
Please contact us at email@example.com to schedule your consultation time! We look forward to meeting you.