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Medical Device Expert News

EU MDR Classification Rule 11 – what???

There’s a bit of discussion in Elsmar about EU MDR Classification Rule 11. – Please explain MDR Rule 11 to me. Please feel free to…

Several revised or updates USFDA guidance

9/13/2019 – Format for Traditional and Abbreviated 510(k)s: Guidance for Industry and FDA Staff 9/13/2019 – Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food…