FDA recognises the ISO 14155:2020 as a consensus standard

On December 21st 2020 FDA added ISO 14155:202 on the list of Recognised Consensus Standards. Worth noting is that the FDA highlights its application for post-market clinical investigations: “the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).” Read […]

FREE Webinar – An overview of IEC 62304 Medical Device software

Join us for this free webinar January 25, 2021  •  14.00-14.20 CET Learn more about how you can comply with the IEC 62304 standard in your Medical Device software development and maintenance process. When to apply IEC 62304? Overall development process for a medical device that is or includes Software Main points of IEC 62304 How to […]