Digital solutions are a part of our daily lives, and the use of digital technologies in healthcare is accelerating at a rapid rate. As regulatory authorities and industry partner to bring safe, effective, and innovative digital health solutions to patients and healthcare professionals, it is important to consider novel product features, performance characteristics, development, and lifecycle management approaches that accompany such technologies.
This training session from November 16, 2020, in which member subject-matter experts taught FDA/ORA staff, highlights the evolving digital health medical device regulatory landscape. Topics discussed include:
- Use of “agile” in software development and fulfilling medical device regulatory requirements
- Similarities and differences between embedded software and software as a medical device
- Use of the cloud and cloud storage in medical device software design and development