by Brian | Aug 11, 2023 | New/Updated Regulation, SaMD Related
Boston, August, 2023 We’ve been gone for a bit – as in three years. Did we miss anything? Or, more to the point, is there anything that didn’t change? Well, there was that whole pandemic thing. Amazing that despite the EU MDR and IVDR both written...
by Brian | May 6, 2017 | New/Updated Regulation
Does your legacy CE Marked medical device emit RF? Medical Device Manufacturers who complied with the essential requirements of the R&TTE (Radio and Telecommunications Terminal Equipment) Directive which has been in effect for the past 15 years will have until 13...
