New EU MDR and IVDR: Understanding Key Changes, Impacts and Actions
Tuesday, 20 September | 2:45–3:30pm | Exhibit Hall
Speaker: Theresa Jeary, technical services manager, medical devices certification, LRQA
With the publication of the new EU Medical Device and IVD Regulations, it is critical to understand the key changes and impact they will have on manufacturers.
The revised regulations seek to ensure medical device safety in two important ways: first, by strengthening the rules for placing devices on the market; and second, by tightening surveillance once they are available.
These major revisions will require some changes to the way manufacturers do business - including applying the risk-based classification matrix, managing product conformity, improving traceability and creating additional clinical and performance evidence.
Manufacturers need to be proactive in implementing the new regulations. Join this session to gain an understanding of the key changes, impact, transition phase and key steps to be taken.
Tuesday, 20 September | 3:30–4:45pm | Meeting Room LL21C/D
Speaker: Susan Mecca, medical device senior technical manager, LRQA
Get practical guidance and real-world application and implementation of some of the new additions and revisions in ISO 13485:2016, particularly those concerning risk management and the interconnection with other regulatory requirements to the corresponding Medical Devices Directive (MDD) and In Vitro Diagnostic Medical Devices Directive (IVDD).
You won’t want to miss our “Top 10” list of pitfalls to avoid. Plus, we’ll cover common misperceptions, tips and hints on compliance and other ideas for understanding and transitioning to the new standard.
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