Futureproofing Your Medical Device QMS for Global UDI Expansion

The Unique Device Identification (UDI) system was conceived as a means of harmonizing identification of medical devices throughout the distribution chain and at the point of use. UDI is required on labeling for Class II and III devices sold in the US (Class I enforcement begins September 2022), and you are likely aware that it’s coming soon under the EU MDR. Less commonly known is the fact that other countries and regions around the globe are also beginning to require […]

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ISO/TR 20416: Best Practices for Medical Device Postmarket Surveillance

How do I define a PMS objective? What postmarket data needs to be collected? How do I analyze it? What’s the connection to other QMS processes such as risk management? As many QA/RA practitioners know all too well, these questions are not well addressed in ISO 13485:2016 and ISO 14971:2019. The goal of this technical report (it’s not a full standard) is to share best practices on how to interpret the general postmarket requirements of the European Medical Device Regulation […]

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EU MDR Vigilance Reporting Requirements and MEDDEV 2.12-1 Rev 8: What Has Changed?

Important: Since the new EU MDR will become mandatory for all postmarket activities beginning May 26, 2021, medical device manufacturers need to ensure that their procedures are updated and employees responsible for vigilance reporting are trained on the change in reporting timeline. What About MEDDEV 2.12-1 Rev 8? MEDDEV 2.12-1 Rev 8 was published in January 2013 and provides guidance to medical device manufacturers on market surveillance. It continues to be the primary guidance document for vigilance reporting, even with […]

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Medical Device Incident and Adverse Event Reporting Timelines in 6 Major Markets

It’s 3:00 p.m. on Friday and you’re ready for the weekend after a busy week. All of a sudden you are jolted back to reality by an email about a serious incident at a French hospital involving your company’s heart monitor. Details are sketchy and somewhat lost in translation. It’s now 9:00 p.m. at your office in Europe. They are closed for the weekend and you can’t get more details. Can it wait until Monday? If you’ve been in your […]

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