Clinical Evaluation in the EU for Medical Devices: Understanding the Changes in MEDDEV 2.7.1 Rev 4 and Their Impact

FREE ON-DEMAND WEBINAR

Clinical Evaluation in the EU for Medical Devices:

Understanding the Changes in MEDDEV 2.7.1 Rev 4 and Their Impact

A new revision of MEDDEV 2.7.1 is now available and this revision represents a complete rewrite, with massive changes.

The new MEDDEV is both more instructive, and more prescriptive in particular regarding the use of evidence from equivalent devices.

So what exactly are the implications of all these changes for device manufacturers?

How does this affect your CERs?

How long is the transition period going to be? (Hint: there’s typically no transition provided for the MEDDEVs).

Join us for this free, 60 minute webinar, presented by our guest Keith Morel, VP of Regulatory Compliance at Qserve Group US Inc., on July 21st.

Watch the webinar

Specifically, this webinar includes:

- - What is MEDDEV 2.7.1. Rev 4 for Clinical Evaluation in EU and why exact does this matter to device makers?
  - What are some of the most significant changes? (There are a lot of them)
  - How does it align with the changes to the new EU MDR?
  - In what ways will demonstrating “equivalence” now be harder?
  - How often you must update your CERs now and what qualifications the evaluators must have?
  - How should you prepare for the increased notified body scrutiny?
  - How do you perform a clinical literature review to meet the new expectations?
  - Do you need to write a CER for CE Marking? If not, when else do you need to do this and with what focus?

Who Should Attend:

- - Medical Device Presidents and CEOs
  - Regulatory Affairs Professionals and Management
  - Quality Professionals and Management
  - Clinical Affairs Professionals and Management
  - R&D Engineers and Management

Hosted by

Presenter: Keith Morel

VP Regulatory Compliance, Qserve Group US Inc.

Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru

qserve_logo

About Qserve Group

Qserve Group is a global leading medical device consultancy group with all consultants formerly holding positions at medical device manufactures, European Notified Bodies, US FDA or Chinese CFDA. Their mission is to support all medical device manufacturers with a practical approach, translating existing regulations to understandable requirements, to guide manufacturers in gaining and maintaining official market access for their safe and qualitative medical devices without making regulatory more complicated than it already is.

About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

Greenlight Guru QMS

Featured Capabilities:

SMART-TRIAL by
Greenlight Guru

Featured Capabilities:

Greenlight Guru Academy