One of the things that makes Charlton Regulatory Consulting different is my software engineering background. I still like to solve the engineering problems facing the world of SaMD, from the real-world medical software issues such as training AI, machine vision, signal processing and good user interface design, to the software and tools engineers, testers and QA/RA professionals use to get the job done.
I aim to maintain helpful resources for software engineers, testers and QA/RA professionals in our public GitHub for all to access.
I've started with the resources I have used previously to validate the MEDDEV 2.12/1 MIR and FSCA form XML exports in the meddev-xml project. While you'll find the XML schema for the MEDDEV 2.12/1 MIR forms over at the Europa website, links to the schema for the FSCA form no longer work, so I've made these available in this project, together with some pointers on how to use the schema.
As part of this project, I'll be making useful spreadsheet and industry standard ticketing tool versions of the MIR and FSCA form available that provide much better sharing, while offering the same XML outputs that you can upload to the MHRA and BSI vigilance portals.
The API for the MHRA MORE portal offers even more automation and integration, and as Eudamed is pieced together, countless more integration opportunities should arise, and this is where Charlton Regulatory Consulting can help. With my unique blend of regulatory experience and software background, I can help you and your team put together systems that really work to fulfil your regulatory post-market and vigilance duties as a medical device manufacturer.