Menu

The EU Medical Device Regulation (MDR): Implementing Changes

Register
When:
June 19, 2018 | 8:00 am - 3:30 pm
Where:
Massachusetts Medical Society
860 Winter St
Waltham, MA 02451, USA
Cost:
$ 175
Contact:
MassMEDIC
617 414-1340
info@massmedic.com

The same organizations that bring you the Annual FDA Update program each December – ASQ Biomedical Division/New England Discussion GroupMassMEDIC and RAPS – present The EU Medical Device Regulation (MDR). Join your medical device colleagues for a day of briefings on breaking regulatory news from the EU. This day-long session will feature presentations on the European Union’s Medical Device Regulations; changes in IVD Regulations; MEDDEV 2.7.1 Rev 4; the EU Risk Management Plan, and a Q&A session with the day’s speakers.

Agenda

7:00am

Registration / Continental Breakfast / Networking

8:00am

ASQ BioMedical NEDG / RAPS Boston Chapter

EU Regulations – What’s Changing and Why?
Bill Enos, Commercial Director, Medical Devices Americas at BSI
Paul Brooks, Executive Director, RAPS

8:45am

IVDR – Big Changes Coming in 2022
Glen Emelock, Lead Auditor & Technical Expert, National Standards Authority Ireland (NSAI); Senior Partner, CRO Group

9:30am

MDSAP – Breaking News from Health Canada

13485/2016: Prevailing non-conformance findings update

9:45am

Networking Break

10:00am

MDR Deep Dive
Bill Enos, Commercial Director, Medical Devices Americas at BSI, and other industry experts to be announced

Changes in Classification, Conformity Assessment, GSPRs, Technical Documentation/Post Market Surveillance

12:00pm

Luncheon

1:00pm

Changes in EU Clinical Data Requirements and Expectations
Maria Donawa, Donawa Lifescience Consulting, Inc.

An examination of changes related to clinical data under the MDR, role of MEDDEV 2.7/1 Rev4, planned EU clinical evaluation guidance documents for aiding compliance with the MDR, and importance of an effective clinical data strategy.

Changes in EU Risk Management Plan
Chad Quistad, Director, Intelligence & Technical Excellence, Regulatory and Quality Solutions (R&Q)

2:45pm

Q&A

3:30pm

Program Adjourns

Register