Welcome to the Advanced Manufacturing West 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.
Don Pohl (Manager of Biological Safety and Validation, NAMSA)
Date: Tuesday, February 5
Time: 9:50am - 10:30am
Track: Classroom Seminar
Vault Recording: TBD
Audience Level: All
What is EU-MDR and is your device technical documentation updated to meet the European Union’s (EU) Medical Device Regulation (MDR) 2017/745 General Safety and Performance Requirements? If not, this session will provide best practices and meaningful tips for manufacturers with devices sold under CE marks and will explain how the EU MDR requirements supersede current EU MDD 93/42 and 2007/47 requirements as they relate to Biocompatibility throughout the full medical device lifecycle.
Also discussed will be information on the specific areas of the EU MDR that enhance ISO 10993-1:2018, as well as other guidelines that support EU MDR requirements for deeper assessment, reduction and control of Biological Risk as they relate to patient concerns.
Lastly, critical MDR information will be provided based on NAMSA’s many interactions with EU Notified Bodies and agencies pertaining to the newly expanded requirements.