Join Our Upcoming Webinar

On Tuesday, 22 Feb. at 11 a.m. ET, RQM+ will host a webinar: “Best Practices and Processes for Integrating CERs and Post-Market Surveillance Under EU MDR.” Fill out the form to register now.

What You Can Expect to Learn

With a variety of new requirements detailed in EU MDR, integrating the clinical, regulatory, risk management, and post-market documentation is a difficult and confusing task for organizations of all sizes. Most medical device manufacturers are now familiar with the general requirements, but there are still plenty of stumbling blocks, including a long list of overlapping requirements and consistent information that must be included in a variety of plans and reports. 

In this webinar, we will briefly explain how the data inputs and outputs for these documents are interrelated and provide guidance on how to share information throughout the organization to streamline processes and ensure consistency.

Notified bodies expect to see consistent information across all documentation, but with multiple teams working on different elements, the reality is that many manufacturers are encountering:

  • Inefficiencies through duplication of effort
  • Notified body findings because of inconsistencies
  • Missed deadlines due to of lack of coordination between teams

Using five common MDR certification scenarios, this webinar will provide best practices and processes such as:

  • Understanding the annual CER lifecycle
  • Creating related documents concurrently
  • Strategizing for literature search plans and reports
  • Knowing what data must be collected and assigning responsibility

Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). 

Meet the RQM+ Experts:

jon gimbelJon Gimbel, Ph.D.
Executive Director, Technical Leadership, Clinical & Post-Market Practice

Jon has a Ph.D. in mechanical engineering and more than 20 years of experience with medical devices. Jon is a prominent member of the RQM+ EU MDR and IVDR leadership teams, and also provides expert technical guidance for the company’s clinical practice.

"As a consultant, I’m involved in a wide range of projects which puts me in a position to monitor how regulatory bodies are enforcing the regulations. This enables me to help our clients navigate the gray areas and avoid common pitfalls so they can keep their devices on the market."


kuttiJaishankar (Jai) Kutty, Ph.D.
VP, Intelligence & Innovation

Jaishankar "Jai" joined the RQM+ clinical team in February of 2021 after seven years at BSI where he held CE marking technical and clinical leadership roles. He is the captain of his underwater bowling team that can also build suspension bridges using floss picks and paper clips. If that means nothing to you, when he is not running with the queen or waltzing with the bulls, he is best at leveraging his unique blend of expertise combining cardiovascular product development and CE marking-experience, towards supporting our clients with regulatory solutions and developing clinical strategies. His fresh-from-the-notified body perspective brings great insights and creative approaches to our clients.

"The paradigm shift in EU regulatory/clinical is real but it isn’t quite like mapping Mars either. Along with the talented, knowledgeable team at RQM+, I’m committed to helping retain legacy devices on the market and ensuring patients can benefit from innovative technologies."

 

Fill out the form to register for the webinar