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 | 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 | Jul 4, 2016 | Guidance Documents
The latest revision of MEDDEV 2.7.1 published last month is more or less a total re-write, and may up-end manufacturer’s clinical plans as well as studies underway to support CE Marking but not yet submitted in tech file or design dossier. In line with the...
