UDI and the EU MDR: What You Need to Know to Comply
Date: Thursday, 16 November 2017,11:00 AM Eastern/4:00 PM GMT, 1 hour duration
Join medical device labeling and data experts from PRISYM ID and Reed Tech to learn about the UDI aspects of the new EU Medical Device Regulation (EU MDR) in this free webinar.
- EU MDR Summary and Timelines
- EU MDR Labeling & Data Requirements Details
- UDI Labeling & Data Lessons Learned in US and Application to EU
MEET OUR SPEAKERS
Chris Lentz, VP of SaaS Business Development, PRISYM ID, manages the SaaS Cloud Solutions team and maintains relationships with customers to ensure on-going feedback and development. He works closely with a GxP focused cloud provider and PRISYM ID’s test and validation experts to deliver compliance oriented solutions for the Life Sciences sector.
Chris has more than 25 years' experience in enterprise software solutions and holds an MSc in Computing for Commerce and Industry.
Phil Dray, Sr. Test and Validation Engineer, PRISYM ID, oversees regulatory compliance with FDA, MHRA, EU and GMP requirements for Life Sciences software products. He also ensures alignment of validation documents and processes with current regulatory guidance and provides onsite training for PRISYM ID’s Life Sciences products.
Phil has 24 years of experience on the PRISYM ID team, working in the areas of electronics, computing and customer support.
Gary Saner, Sr. Manager of Information Solutions, Reed Tech, is a subject matter expert on UDI and other structured content submissions to regulatory agencies. Gary has over a decade of experience in the Life Sciences industry and has worked for more than 30 years in the areas of software development, process management and data conversion.