Category: Auditing

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

EU MDR & IVDR Updates

UPDATED June 11, 2021 Shown below is a list of European Notified Bodies that have been designated under the 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 table up to date. Email us with corrections or additions. YES! EU Notified Bodies […]

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

Virtual Medical Device Inspections and Audits: Here to Stay?

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 out of pure necessity. Still, regulators weren’t convinced about the benefits of this newfangled video technology […]

» Read more
All Topics, Auditing, Remote Meetings

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 […]

» Read more
All Topics, Auditing, MDSAP

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 […]

» Read more
All Topics, Auditing, Remote Meetings
1 2 3 … 5