Ali Kissinger

Are You IEC 63204 Compliant?

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.

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