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MDR | IVDR | SSCP Requirements | Safety and Performance (SSP)

Overcoming Challenges and Streamlining Your SSCPs and SSPs

In case you missed it, the latest presentation in our webinar series covers the new requirements under EU MDR and IVDR: the Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP), respectively. It’s no surprise that manufacturers are finding it challenging to produce these reports because they are completely new to everybody. 
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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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team members | IVDR

Carlos Galamba Joins RQM+ as IVD Director

RQM+ is excited to announce the addition of Carlos Galamba as IVD Director after several years working for one of the largest Notified Bodies leading a global IVD team and assisting in the IVDR transition efforts.
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team members

Dr. Andrew Tarnaris Joins RQM+ as Medical Director

RQM+ is excited to announce the addition of Dr. Andrew Tarnaris as Medical Director. With a background as both a medical doctor and notified body clinical expert, he represents an excellent example of our unique combination of clinical and regulatory experience.
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MDR | Clinical Evaluation Report

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

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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RQM+ Case Study: Effective Managed Outsourcing for EU MDR

THE PROJECT A leading global company offering medical technology, services, and solutions engaged RQM+ to help four business units prepare for the EU Medical Device Regulation (MDR). Specifically, RQM+ is focused on assessing and remediating gaps in MDD technical files and building compliant MDR technical documentation files for submission.
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[Webinar] Strategies for Overcoming the Biggest Challenges in Achieving IVDR Compliance

The latest addition to our webinar series covers the biggest challenges in IVDR compliance. With hundreds of MDR submissions under our belts and a number of clients who have already received findings from their IVDR applications, we have learned a lot about the regulation, the guidance that surrounds it, and what notified bodies expect to see.
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Design History File

How to Prepare a Design History File for FDA Inspection

Food and Drug Administration (FDA) inspections are stressful, especially if your documentation isn’t audit-ready. Creating and maintaining a compliant design history file (DHF) will help ensure that when the time comes, you’ll be ready for an FDA inspection that results in minimal findings.
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Leveraging PMCF Surveys for EU MDR Compliance - Part 2

When to use Post-Market Clinical Follow-up (PMCF) Surveys under the European Union's Medical Device Regulation.
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Lessons Learned: 2020 RAPS U.S. and Euro Convergence

RQM+ sponsored both RAPS U.S. and Euro Convergence conferences in 2020 and we also led and provided subject matter experts for two panel discussions. Our experts pulled together the highlights from both conferences and summarized them by category for our readers.
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