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MDR | Clinical Evaluation Report

What Are Clinical Benefits and How Do You Evaluate Them in Your CER?

The rollout of the EU MDR has created new challenges for medical device manufacturers, including those that have had devices on the market for a long time. One area of increased focus is the need to quantitatively establish the clinical benefits to patients from the device based on relevant and specified clinical outcome parameters. This requirement is being strictly enforced by notified bodies and, although this can be straightforward for some types of devices, for others, it can be difficult to define the benefits to the patient.
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MDR | Clinical Evaluation Report

RQM+ MDR Clinical Evaluation Roadmap: An Interview with Dr. Jai Kutty

on 9 September 2021 | By RQM+ Subject Matter Experts
The introduction of MDR caused a major transformation in the medical device industry. Manufacturers continue to grapple with all elements of compliance, but clinical evaluation presents unique challenges. RQM+ is committed to helping clients navigate these challenges with former notified body leaders who understand what reviewers are looking for when evaluating clinical evidence.
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CER | Clinical Evaluation Report | EU MDR | Clinical Evidence

Preparing your CER for MDR [Upcoming Webinar]

on 13 November 2017 | By Stephen Biernacki
The upcoming EU MDR requires enhanced clinical evidence to support the device whether you have Class I or Class III products. For products that have been on the market for a long time there may be limited or no clinical studies, and yet, the new European Medical Device Regulations require your organization to provide clinical evidence on all your devices. R&Q's next Intelligence Series webinar, Preparing your CER for MDR: Gathering Clinical Evidence, will be held on Tuesday, Novemer 28th from 1:00pm - 2:00pm EST.  The presentation slides, webinar recording, and Q&A will be made available to registrants. Register in seconds at the link below, and read on for full webinar details. We hope you'll join us!
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remediation | FDA | Case Studies | Clinical Evaluation Report | MEDEV 2.7/1

Clarifying the Clinical Evaluation Requirements: A Case Study

on 1 August 2017 | By Stephen Biernacki
About R&Q's Case Studies: We hope this Clinical Evaluation Report case study is valuable to you. Here are our currently available case studies. Subscribing to our blog is the best way to know when future case studies and other resources are available. Questions on this particular subject? Contact us. Challenge Design changes and MEDDEV 2.7/1 rev 4 compliance. The client was implementing multiple design changes on a Class III implantable heart transplant device that required a submission to the Notified Body. As part of this submission, the Clinical Evaluation format needed to be updated to provide clarity and comply with MEDDEV 2.7/1 rev 4. The Notified Body provided feedback on the prior clinical evaluation reports and the client needed assistance in interpreting and addressing the feedback. The primary roadblocks / challenges were interpreting the information provided by the client, identifying and requesting any missing or insufficient documentation, and ensuring the information was comprehensive and understandable to the Notified Body once included in the Clinical Evaluation Report.
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Clinical Studies | Case Studies | Clinical Evaluation Report

When Benefit Outweighs Risk: Creating a Successful Clinical Evaluation Report - A Case Study

on 18 February 2016 | By Stephen Biernacki
About R&Q's Case Studies: We hope you enjoy our third case study. View all of our available Case Studies. Subscribing to our blog is the best way to know when future case studies are available.   Challenge High volume of data... and differing opinions. A client's product is utilized on critically ill patients in intensive care units. As a result, comorbidities and adverse events during the use of the device are inevitable. There were more than a thousand customer complaints and hundreds of serious adverse events reported to public databases for the subject device and comparative devices. Notified body findings on the previous clinical evaluation reports and internal conflict over the requirements added to the confusion.
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