Event Details
24 hours
Available virtually
In the course, you will receive a general overview of the Medical Device Regulation, the Implementation Timelines, Paths to CE Mark, and a deep dive into the significant articles that affect medical device manufacturers.
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Please contact us if you are interested in private training for this workshop.
24 hours
Available virtually
The EU Medical Device Regulation (MDR) is far more complex than the Medical Device Directive (93/43/EEC) it replaces and presents new challenges, including strict new requirements for Clinical Data, risk management, postmark surveillance, and supplier management.
QSG’s three-day course on the Medical Device Regulation 2017/745, with a focus on the requirements for Medical Device Manufacturers, provides comprehensive instruction on the EU MDR. It covers every aspect of the regulation and identifies key topics and changes, including economic operators and new roles associated with EU MDR, standard requirements that must be met by all manufacturers regardless of class, and the pre- and post-market requirements of conformity assessment.
In the course, you will receive a general overview of the Medical Device Regulation, the Implementation Timelines, Paths to CE Mark, and a deep dive into the significant articles that affect medical device manufacturers.
Included in the presentation is a copy of the MDR, a gap analysis template, and a sample of the General Safety and Performance Requirements checklist with highlights of significant differences from the MDD Annex I Essential Requirements Checklist.
The course is especially suitable for:
At the end of this workshop, participants will be able to:
Chris, Angelo and Barbara,
The recent meeting “What we can learn from FDA Warning Letter” was an excellent and exactly what I was looking for. Please keep me on the list for future meetings. Real professional of you folks. I have given your companies information out to an acquaintance from ASQ as a source for training for internal auditing. Looking forward to a long relationship with your team.
Hi Angelo,
Great ISO 13485:2016 Internal Auditing class, honestly the most well run and informative class I’ve taken.
Hi Angelo,
We are satisfied with the process and the report. Gordon does a good job! He is up on the regulations and what we need to focus on. I have found in past years what he points out is what comes up on the radar with the Notified Body. It helps us to be ready for the process.
Thanks for letting us know!
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