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COMMISSION IMPLEMENTATION DECISION M/575 was issued 14 April 2021: This is a list of standards the EU Commission is hoping to Harmonize under MDR and IVDR. One of the issues is the HAS consultant has issued a negative assessment on
Notified bodies can now do remote audits for the MDR and IVDR — Member states need to Notify the EU Commission of Notified Bodies not conducting on-site audits & the period of time this will not be happening. So remote
Just found out that the HTML listing of the Harmonized Standards listings are not available anymore. Not that they have been up to date of late anyway but still I refer to them a lot. So, when you search for
As a Senior Contributor to InCompliance, many years I am asked to update my articles to be placed in the Annual Guide but rarely do 2 of my articles show up in the Guide in a year. This year 2
The Medical Device Coordination Group (MDCG) is meeting on March 11 & 12th to hold a series of meetings. Part of these meetings includes hearing feedback from industry and Notified Bodies on stakeholder preparedness for the application of the MDR