EU MDR Workshop

9/25/2019

8:45 AM - 12:15 PM

Location: Room 052A

Panel Session Speaker(s)

Jon Gimbel, PhD

Executive Director and CER Business Unit Lead
Regulatory & Quality Solutions (R&Q)
PS

Pat Shafer

Grant Thornton
Erik Vollebregt

Partner
Axon Lawyers
Ibim Tariah, PhD

Vice President of EU MDR and IVDR Consulting Services
Regulatory & Quality Solutions (R&Q)
MZ

Marty Zuzulo

Grant Thornton
Dona Occhipinti, MPH, CCRP

Clinical Compliance Lead Specialist and EU MDR Clinical Evaluation Lead
Hillrom

Theresa Miles

Account Director and Director of Sales Training
Regulatory & Quality Solutions (R&Q)

8:45 AM - 9:45 AM
One Year In: What We’ve Learned from Creating 100's of MEDDEV 2.7/1 Rev. 4 and EU MDR Compliant CERs (It’s Harder Than You Think)
Jon Gimbel, PhD – Regulatory & Quality Solutions (R&Q); Ibim Tariah, PhD – Regulatory & Quality Solutions (R&Q); Dona Occhipinti, MPH, CCRP – Hillrom; Theresa Miles – Regulatory & Quality Solutions (R&Q)
10:00 AM - 11:00 AM
Clarifying Impact: Determining and Driving Quality and Technical Documentation Compliance
Pat Shafer – Grant Thornton; Marty Zuzulo – Grant Thornton
11:15 AM - 12:15 PM
MDR Readiness Seven Months from Date of Application
Erik Vollebregt – Axon Lawyers