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It’s becoming increasingly more difficult for medical device manufacturers and consultants to stay up to date with the proliferation of changes in the regulatory landscape. With several hundred changes written into the 60601-1 Amendment alone, suffice it to say that
Big News!!! IEC published ahead of schedule 6 of the 8 standards from the IEC 60601 Amendments Project. These standards are in Consolidated format meaning the latest edition plus amendments are all consolidated together. IEC notes this as a CSV.
Join us on Wednesday, July 29, 9 AM Pacific (Noon Eastern), for a live Zoom conversation with Leo Eisner the “IEC 60601 Guy” of Eisner Safety Consultants and Rob Packard of Medical Device Academy. Learn about some of the major changes from the IEC 60601 Amendments coming during this Zoom conversation. See the infographic to get an understanding of which standards are being updated, when the updates are estimated, how long the proposed transition period is, what are some of the concerns to consider, and what ways can we help you prepare and train your staff up for these changes.
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
Read the article I wrote for InCompliance Magazine recently. I just got back from China at the end of Oct 2019 where I was at IEC meetings for 2 weeks working on IEC 60601-1, edition 3.2 and it’s collaterals and