A complaint can come from any source – a patient, a doctor, or someone else involved with a medical device – anyone unhappy with the product or service. Complaints also arise from internal review and/or testing, where an issue is discovered and reported through designated channels. With Software as a Medical Device (SaMD) complaints can even originate from error logs.

Companies that develop Medical Device Software (MDSW) need to consider both the requirements of the EU’s Medical Device Regulation (MDR), and the standard IEC 62304. That’s because the software development practices, outlined in IEC 62304 – Medical device software: Software life cycle processes help to ensure that standalone software, or software components designed to be used alongside or in combination with a medical device meet the safety and performance requirements set out in the MDR. Here’s what makes it essential for makers of MDSW.

Getting a medical device market-ready is a key milestone. That’s largely because meeting regulatory requirements – like the EU’s Medical Device Regulation (MDR) – is such a huge challenge. Regulatory consultancy can help. The big question is of course how much that costs. How do you put a price on getting the right support with regulatory compliance?