RQM+ Vice President of Global Regulatory Affairs (and former BSI), Jaishankar Kutty, Ph.D., discusses the process of reviewing clinical evaluation reports (CERs) by notified body reviewers under the EU MDR in our newest video clip.
In the end and more than anything, manufacturers must provide a clear and comprehensive story in their CERs to facilitate the review process. 

How does a notified body clinical reviewer approach a review? | MedTech Voices

RQM+ industry-leading experts and often special guests discuss regulatory, quality, clinical, lab, and reimbursement challenges MedTech companies are facing.

RQM+ is the world's leading MedTech service provider offering consulting, clinical trial, lab, and reimbursement services, as well as technology solutions to support the entire product lifecycle. With more former FDA, Medicines, and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties.

Please visit RQMplus.com to learn more.

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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.


"Encouraging and driving a strong culture of quality allows a company to effectively manage the details in a collaborative way."


Scott Edwards, Managing Director at RQM+, shares his extensive industry experience and personal journey in our latest 

Scott Edwards, Managing Director | Excellence Spotlight

This show was recorded 25 April 2024. We encourage you to download the IVDR timeline presented at the beginning of this session by ⁠⁠completing the form on this page⁠⁠. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the ⁠⁠⁠Knowledge Center⁠⁠⁠ or ⁠⁠⁠Events⁠⁠⁠ pages at RQMplus.com.
Thank you for tuning in. 

Live! #78 – Behind the Scenes with BSI Head of IVD Notified Body, Alex Laan

FDA Releases Final Rule on Laboratory-Developed Tests (LDTs): What You Need to Know | MedTech Voices

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.




Samantha Howard, Study Director (Jordi Labs) | Excellence Spotlight

In this special bonus clip from our Excellence Spotlight series, Sr. Director of Data Operations (Clinical Trials) Noel Keegan takes a deep dive into clinical data management.


From the transition to electronic systems to the exciting potential of AI, Noel reflects on the evolution he's witnessed over his 16+ year career. He breaks down the key aspects of data management across the study lifecycle:




How does a notified body clinical reviewer approach a review? | MedTech Voices

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