by Brian | Aug 26, 2023 | Guidance Documents
Rockville, August, 2023. FDA revised and issued “Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors”. The document represents finalized guidance, superseding the first guidance issued in September 1998, and updating draft...
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 | Nov 6, 2019 | Guidance Documents, SaMD Related
Brussels, November, 2019 With a little more than a half year to MDR implementation, the EU Medical Device Coordination Group released MDCG 2019-11, a 28 page Guidance on Qualification and Classification on Software in Regulation (EU) 2017/745 MDR and 2017/746...
by Brian | Aug 24, 2018 | Guidance Documents
August, 2018, Symonston, Australia. Australia’s TGA (Therapeutic Goods Administration) issued a guidance on electronic instructions for use (eIFU) for medical devices earlier this month. Similar to current EU requirements, Australian regulations require all medical...
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...
