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...
