When it comes to producing Software as a Medical Device (SaMD), we know that there are standards to guide us in along the path of...

How many software medical device and non-medical device healthcare software manufacturers out there are fully aware of their need to...

One of the things that makes Charlton Regulatory Consulting different is my software engineering background. I still like to solve the...

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...