Iain CharltonJun 9, 20238 minSoftware Quality Management Basics - A Brief GuideWhen it comes to producing Software as a Medical Device (SaMD), we know that there are standards to guide us in along the path of...
Iain CharltonApr 20, 20234 minA Brief Guide to Implementing a DCB0129 Clinical Risk Management FileHow many software medical device and non-medical device healthcare software manufacturers out there are fully aware of their need to...
Iain CharltonMar 30, 20231 minIntroducing Our GitHub ResourcesOne of the things that makes Charlton Regulatory Consulting different is my software engineering background. I still like to solve the...
Iain CharltonFeb 3, 20233 minCan The New PSUR Guidance Help Build Better Post Market Surveillance?The MDCG published their PSUR guidance and template last December (see here if you haven't yet picked this up). I think this is a good...
