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

EU MDR & IVDR Updates

UPDATED October 23, 2020 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, the European Commission has stated that 44 MDR and 11 IVDR applications have been received. That represents a surprising 86% of current MDD NBs and 50% of IVDD NBs. The organizations on the list below account for more than 80% of […]

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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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Wrapping It Up: Conducting an Audit Closing Meeting That Compels Action

You’re mentally exhausted and the end of your medical device audit is in sight. Why not just call it a day and hold a quick wrap-up meeting? Although you and everyone else are eager to get out the door, it’s important that you thoroughly summarize your findings and communicate them to the auditee team immediately after the audit. Yes, everything you say will likely be documented in your report, but this is a key opportunity to add emphasis to certain […]

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Tips on Conducting Medical Device Audit Opening Meetings Based on Training 130,000+ Auditors

For a new auditor, the opening meeting is critical. The manner in which you conduct yourself, and how organized you are, establishes your credibility and sets the tone for the audit to follow. If you appear tentative and unorganized, your audit will probably not go smoothly. With that in mind, here are some tips on how to conduct your next opening meeting. This is based on our experience training more than 130,000 auditors over the last 50 years. Checklist to […]

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