Developing IEC 62304 compliant software isn’t trivial. With this, you must develop software that supports its intended use, while also complying with ISO 13485, ISO 14971, and IEC 62304 international standards. Then, if you include GDPR in the mix, you can easily get lost and overwhelmed – unless you leave it up to an expert. IEC 62304 is the gold standard for medical device software, but its importance goes far beyond ensuring regulatory compliant manufacturing and software development. Let’s start from the beginning.
The third edition of risk management process standard ISO 14971 is now available. This blog post summarizes the changes in the new edition of the standard and discusses what the changes mean to medical device development professionals.