Category: Auditing

Virtual Medical Device Inspections and Audits: Here to Stay or a COVID-Era Blip?

Industry has a tendency to adapt quickly to changing market conditions, especially when money is involved. Government, not so much. When COVID hit the US in March 2020, in-person audits came to a screeching halt. Within months, when it became clear that the pandemic wasn’t disappearing anytime soon, medical device and IVD manufacturers pivoted and within a few months were conducting remote internal audits. Still, regulators weren’t convinced about the benefits of this newfangled video technology thing. That’s finally beginning […]

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All Topics, Auditing, EU In Vitro Diagnostics Regulation (2017/746), EU Medical Device Regulation (MDR 2017/745)

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, and as of late 2019, nearly half of US manufacturers qualified for an MDSAP audit while the rest received traditional FDA inspections. At Oriel STAT A MATRIX we get many questions about MDSAP, […]

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All Topics, Auditing, MDSAP

Which EU Notified Bodies Have Been “Designated” Under the MDR 2017/745 and IVDR 2017/746?

EU MDR & IVDR Updates

UPDATED February 18, 2021 With the MDR deadline approaching, many medical device manufacturers do not know for certain whether their Notified Body (NB) will be designated and when! There is no current list of Notified Bodies seeking designation. However, as of December 2020 the European Commission has stated that 90% of current MDD NBs and 71% of IVDD NBs are seeking designation. The problem is that although many NB’s are in queue for designation, COVID has stalled progress because on-site […]

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All Topics, Auditing, EU In Vitro Diagnostics Regulation (2017/746), EU Medical Device Regulation (MDR 2017/745)

Is Your Medical Device Company Ready for a Remote
Audit Using ICT?

If you’re among the millions working from home, you don’t have to despair about falling behind schedule with your audit plan. Technology can keep you on track. Working remotely is nothing new, and the pros and cons of doing so are well understood. Yet most audits are still conducted in person. Why? Well, some aspects of auditing are difficult to perform remotely, especially when a direct observation of manufacturing processes or paper documents is involved. Also, the human connection is […]

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All Topics, Auditing, Remote Meetings
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