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COVID-19

Crisis Survival Tip #3: Nurture Employee and Client Relationships

The past year was an extraordinary one and gave us plenty of food for thought, whether personally or professionally. At RQM+, we have been thinking about the leadership lessons we learned – RQM+ Executive VP, Lisa Casavant, recently wrote about how we managed to hold on to our employees, and RQM+ President, Maria Fagan, reflected on how the business continued to grow throughout the COVID-19 pandemic.
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COVID-19

Crisis Survival Tip #2: Stay Committed to a Strategic Vision

The past year has left us with many lessons about leadership during a crisis. From the very beginning of the COVID-19 pandemic, we made a clear intention to stick to our values as a company, though we knew this would not be a straightforward path. RQM+ EVP, Lisa Casavant, recently wrote a post about how we prioritized the retention of our people. We’re pleased that we made this decision since we were in a much better position once demand recovered.
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Safety and Performance (SSP)

An Overview of Summary of Safety and Performance (SSP) Under IVDR

EU IVDR 2017/746 includes a requirement to write a summary of safety and performance (SSP) for Class C and D IVDs. This is a new requirement that wasn’t included in IVDD. The goal of this requirement is to enhance transparency and provide adequate public access to summarized data on safety and performance to intended users, which includes both professionals and laypeople when applicable.
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COVID-19

Crisis Survival Tip #1: Hold On To Your People

As we continue to cope with the after-effects of the COVID-19 pandemic, we’ve been reflecting on the past year and how we survived as a business. Though every company should be prepared for the unexpected to happen, it is difficult to anticipate an event on the scale of a global health crisis. At RQM+ (then R&Q), we were very determined from the very beginning to preserve our values, and we’re gratified that this approach paid off. This post is part of a series sharing how we addressed some of the challenges brought about by the pandemic.
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IVDR

[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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medical device recall management

RQM+ Quick Guide to Medical Device Recall Management

Medical device recalls are daunting in many ways—manufacturers dread them, competitors love them, and patients don’t always understand them. A medical device recall could be a response to patient safety concerns or to unanticipated negative trends. All manufacturers should assume it will happen at some point and do as much as possible to be prepared for it in advance.
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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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IVD regulatory

A Comparison of IVDR to FDA IVD Regulatory Submission Requirements

The European Union’s new In Vitro Diagnostic Regulation (IVDR) May 2022 implementation date is fast approaching. If you sell IVDs in multiple markets, it may be challenging to determine the differences between the IVD regulations in the U.S., the existing IVDD, and the new IVDR. It’s not surprising that global IVD manufacturers are finding it challenging to keep it all straight.
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MDR | EU MDR

The EU MDR Date of Application Has Arrived!

The European Union (EU) Medical Device Regulation (MDR) 2017/745 date of application is here! To celebrate the incredible effort medical device manufacturers have put in so far to get to this point, we have compiled a brief review of the remaining EU MDR timeline and a list of brand new educational content brought to you by RQM+ subject matter experts. 
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MDR | EU MDR

Optimizing your Technical Documentation to reduce NB review time and questions (Medical Devices and IVDs)

Whether you are used to working with a notified body or the MDR/IVDR requirements no longer allow you to self-certify and it’s all new to you, it is more important than ever to optimize your technical documentation. Notified bodies are already swamped with MDR submissions, and as the IVDR deadline approaches and new manufacturers engage them, the bottlenecks will get even tighter for IVD NBs.
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CE Marking

How to Obtain CE Marking Under the MDR

In the EU, CE marking is the system used to demonstrate that products meet the region’s requirements for safety, health, and environmental protection. When a product is labeled with the CE marking, it can be freely traded in the European Economic Area (EEA) without restrictions. 
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