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RQM+ Medical Device and In Vitro Diagnostic Blog
Topic: post market surveillance
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Enhancing Competitiveness in MedTech: Smart Strategies with Regulatory Intelligence
on 6 February 2024 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution
What is regulatory intelligence? Ok, so what on earth are we talking about when we say regulatory intelligence? There are no formal definitions for regulatory intelligence in regulations or standards relating to medical devices or in vitro diagnostic devices. Without delving...
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Overcoming the Most Common Periodic Safety Update Report (PSUR) and Post-Market Surveillance (PMS) Report Challenges
on 18 May 2022 | 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...
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Best Practices and Processes for Integrating CERs and Post-Market Surveillance Under EU MDR
on 21 January 2022 | By Jonathan Gimbel, PhD, RQM+ Vice President, Technical
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...
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Canada Regulations News for Medical Devices and IVDs
on 3 December 2021 | By Nancy Morrison, RQM+
In case you missed it, the Medical Device Regulations in Canada quietly got updated in December 2020. The new regulation intends to boost post-market safety and requires manufacturers to submit a summary report, which is similar to the post-market Periodic Benefit-Risk...
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Integrating Post-Market Surveillance Into Your QMS
on 12 October 2021 | By Amie Smirthwaite BEng, PhD, FRAPS, RQM+ Senior Vice President, Intelligence & Innovation
Now that medical device manufacturers have begun to implement MDR-compliant post-market surveillance (PMS) systems, it is a good time to take stock of common areas of difficulty and inefficiency, and consider how best to address these. Even manufacturers who are continuing to...
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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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No Time for Common Sense
on 27 November 2012 | By Ryan Kasun
Last week, I had a computer issue...not a big issue, more like an annoyance. Nevertheless, I dutifully called our IT support and after a couple of hours of investigation, we determined that the problem could be solved by one of two solutions; change the battery or change the...
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