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UPDATED May 7, 2022 Shown below is a list of European Notified Bodies that have been designated under the EU MDR or IVDR. There is no current list of Notified Bodies seeking designation but some have indicated their intent on their website and we have added them in the pending list below. As Notified Bodies are officially designated, we will add them here. Help us keep this information up to date. Email us with corrections or additions. YES! EU Notified […]

The Medical Device Single Audit Program (MDSAP): Your Questions Answered

Regulators from five countries (US, Canada, Australia, Brazil, and Japan) joined forces in 2012 with the goal of coordinating data gathering and reducing redundant audits for medical device manufacturers. The program has grown quickly. Health Canada led the way and required MDSAP certification starting in January 2019. At Oriel STAT A MATRIX we get many questions about MDSAP, so we have compiled a list of the most common ones. Questions and responses are grouped into the following categories. Who Needs […]

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All Topics, Auditing, MDSAP

Will Your Team Be Ready for a (Live and In-Person) FDA Medical Device Inspection?

COVID-19 significantly curtailed FDA’s ability to conduct surveillance inspections of medical device manufacturers. Most manufacturers have not had an FDA inspector show up at their facility since at least March 2020. However, on July 1, 2021, FDA resumed on-site inspection operations, although it remains to be seen how quickly they’ll get up to speed. There is little doubt that COVID-19 made it more challenging to maintain a quality management system compliant with the FDA Quality System Regulation (QSR). Most non-manufacturing […]

When Will FDA Resume Medical Device Inspections?

Remember FDA inspections? Yes, we know you’ve missed them, and chances are extremely high that’s because an FDA inspector has not darkened your door since early 2020, likely longer. While virtual meetings are the new normal for many business professionals, it’s pretty clear that FDA has begun to transition to live, onsite inspections of domestic manufacturers. But before they can ramp up to full normal inspection operations… …The FDA Has to Dig Itself Out of a Hole As you probably […]

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