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post market surveillance | MDR | IVDR | PSUR periodic safety update report

Overcoming the Most Common Periodic Safety Update Report (PSUR) and Post-Market Surveillance (PMS) Report Challenges

— coauthored by Jan Kloiber, Senior Principal Specialist and Celeste Maksim, Chief of Staff, Clinical and Post-Market Services May 2022 is the one-year milestone for EU MDR and the date of application for IVDR. For medical devices that have already been approved under MDR, annual periodic safety update reports (PSURs) are due for Class IIb and III devices. Since this is the first year and there is still no official guidance, many manufacturers are struggling with meeting the new regulatory requirements.
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MDR | regulatory | IVDR

How Your Medical Director Can Help You Scope SOTA Properly: A Physician's Perspective

State of the art (SOTA) is a key element of the technical documentation required for MDR/IVDR certification. As a new requirement for devices in lower-risk classes, many manufacturers are struggling to provide SOTA context that meets notified body expectations. Whether for new devices or those that have been on the market for a long time, physicians can help manufacturers overcome many of these challenges.
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MDR

Using Chemical Characterization to Achieve Biological Equivalence

In the EU, a device is considered to be equivalent if and only if it fulfills all the requirements of technical, clinical, and biological equivalence. Of these, biological equivalence tends to be the most nuanced and can be a confusing topic for medical device manufacturers—especially since regulators in different global regions don’t always take the same approach. Chemical characterization, which tends to get ignored—but is now a requirement per MDR, Annex II, section 6.1(b)—can help make claiming biological equivalence more feasible when “similarities/differences” exist.
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MDR | IVDR

Europe: 2021 Year-End Review & Looking Ahead to 2022

Co-authored by Carlos Galamba, RQM+ Vice President, IVD Intelligence and Innovation and Nancy Morrison, RQM+ Executive Director, Regulatory & Consulting Services 2021 was another big year in the European regulatory realm as EU MDR and IVDR implementation continued to roll out. Let’s take a look at the highlights and lessons learned that we can apply as we go into 2022.
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FDA | MDR

Software as a Medical Device

on 7 February 2022 | By Brian Hockett, RQM+
Advancements in technology over the past several decades have naturally led to advancements in healthcare. Software as a medical device (SaMD) is particularly poised for growth with one of the latest advancements: the Internet of Things (IoT). Because of this and other factors, the SaMD market is expected to grow at a compound annual growth rate of 21.9 percent from 2020 to 2027, bringing the value to just over $86 million. This growth represents potential lifesaving innovation for providers and patients. However, for manufacturers, especially those that are new to SaMD, it represents new complications in regulatory affairs and risk management.
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post market surveillance | MDR

Best Practices and Processes for Integrating CERs and Post-Market Surveillance Under EU MDR

The EU MDR date of application has come and gone, and most manufacturers are well aware of the new requirements. However, awareness does not necessarily equal effective implementation. One of the main challenges of MDR compliance is creating a strategy that integrates the work of multiple teams, including regulatory, quality, risk management, clinical, and more.
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MDR | IVDR | SSCP Requirements | Safety and Performance (SSP)

Overcoming Challenges and Streamlining Your SSCPs and SSPs

on 8 November 2021 | By RQM+ Subject Matter Experts
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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post market surveillance | MDR

Post-Market Surveillance: A Concise Overview of Requirements

on 5 October 2021 | By Celeste Maksim, PhD, RAC, RQM+
Following the May 2021 deadline, medical device manufacturers now have an MDR-compliant post-market surveillance (PMS) system in place. However, there are still many issues and questions around this topic which need addressing.
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MDR | IVDR

Top 10 Tips on How to Write a PMS Report and PSUR Without an Official Guidance Document

Manufacturers have relied on guidance from the Medical Device Coordination Group and similar organizations to interpret many of the new regulations under EU MDR and IVDR. However, guidance has not been provided for every aspect of the regulation, and application deadlines have not shifted, leaving manufacturers struggling to understand precisely how to be compliant.
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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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MDR | EU MDR

The EU MDR Date of Application Has Arrived!

on 26 May 2021 | By Nancy Morrison, RQM+
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)

on 20 May 2021 | By Nancy Morrison, RQM+
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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Medical Device Report | Complaint Handling | MedWatch | Complaints | FDA | medical device | MDR | Adverse Event | Post Market Vigilance

Complaint Handling Solutions

on 23 May 2013 | By Ryan Kasun
In my last post “Who’s watching your MedWatching”, I commented on some of the common issues manufacturers have with their MDR and complaint handling systems. It’s useful to know what people are doing wrong, but I think it is equally important to know how to solve those issues. So in this post, I’m going to point you to two very good resources that I found that give further insight into how to know if you have a problem, and how to fix your system.
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Medical Device Report | Complaint Handling | warning letter | MedWatch | Complaints | FDA | medical device | MDR | Adverse Event | Post Market Vigilance

Who’s watching your MedWatching?

on 3 May 2013 | By Ryan Kasun
Last year, FDA received almost one million adverse event reports from manufacturers1. Needless to say, the Office of Surveillance and Biometrics has been very busy, and so have manufacturers.
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