A Software as a Medical Device (SaMD) is really a specific kind of medical device. I teach you on this article all that you need to follow to put it on the market. I developed a 3 step program to put any medical device on the market. The Route Plan. You need to plan all before to start your journey. Follow the Medical Device Regulation MDR 2017/745 that should be in place before 25 May 2020.
One pillar for compliance to MDR 2017/745 is the Technical Documentation. To help you build your files, I will help you understand each section and if needed I also built a template for you.
The PRRC is the Person Responsible for Regulatory Compliance and this is a new role required by the new EU MDR 2017/745 and IVDR 2017/746. I explain to you who can be PRRC and what are its responsibilities. Don’t wait to nominate yours as there are also some changes to do with the quality documentation to be fully compliant.
FDA rejects a majority of the 510k submissions due to Substantial Equivalence issues. We propose you to learn how to master Substantial Equivalence and always succeed. Learn also what to do in case of rejection. This article is a Step by Step process to succeed on you Substantial Equivalence section for the process 510(K).