Following on from previous blogs, What you need to know about traceable requirements for medical devicesand How much documentation does my Software as a Medical Device regulatory submission really need?, it’s time to now think about how to organise the complementary risk management, particularly for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).

In part 1, we outlined the key concepts of a quality management system (QMS), explored what a QMS is – and what it is not – discussed why a QMS is required by law and who needs it, and provided an overview of the structure of a QMS. Now, in part 2, we'll move on to the practical side of implementing and managing a QMS effectively. Now then, back to Kipling’s six honest men…

A key piece of the technical documentation for a medical device is a requirement stack that covers the total product lifecycle (TPLC) of that device, including the requirements.

It goes without saying (or you’d think so anyway) that strategic planning goes hand in hand with medical device development for regulatory approval and market success. However, it is often overlooked.

One question we at Hardian get asked a lot is how to classify products for regulatory purposes that take an input from a sensor, and then process that signal using software. The answer depends on the intended purpose of the sensor, and the intended purpose of the output.

Learn how to derive the documentation requirements for SaMD from the safety and risk class of the device and download a free cheat sheet to help you navigate regulatory submissions.

Through our extensive experience of regulatory submissions for SaMD the top five make-or-break success factors are Design Control, Requirements Management, Risk Management, Verification and Validation evidence, and Software Maintenance under Change Control.

If you currently have a UKCA or CE marked medical device on the market you should anticipate unannounced audits to be conducted on your organisation. We explain what they are and how you should be preparing for them.

IEC 62304 is an international standard that defines the lifecycle requirements to develop Software as a Medical Device (SaMD) such that once deployed it is safe, effective, and cybersecure .