Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations Paperback – 26 Mar. 2024

This book is very specialised, but as a non-regulatory co-founder of a SaMD startup I found it incredible! It explains in details the regulatory landscape for medical devices and walks through step by step what has to be done to certify a new product on the markets (UK, EU, US). Reading I was amazed about how clearly and neatly the authorised could talk about the topics that felt (and probably to a degree still feel) like a black magic. Thank you for spending time to put this book together, it would have taken me months to get half of the understanding that you delivered to me in less than a week of reading. This book is a massive time saver for anyone looking to release a medical device.