Compliance support for EU MDR and US FDA regulations and applicable standards: IEC 82304-1, IEC 62304, ISO 14971, and FDA Title 21 CFR Part 11 & 820
This Medical Software Engineering Template helps you adopt best practices for medical software development with minimal effort. With baked-in best practices and domain knowledge, the template greatly reduces the time and effort costs of developing quality digital health products in compliance with the requirements of EU MDR and US FDA regulations, as well as other international standards (IEC 82304-1, IEC 62304, ISO 14971, and FDA Title 21 CFR Part 11 & 820).
This template was designed for developers of:
- software as a standalone medical device
- software as part of an embedded digital health system
- software as a mobile medical application.
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