A great article by Shahid Shah "...If you ask some regulatory affairs folks in medical device companies, they think OSS is too “dangerous” for use in safety critical systems. The most common excuse given by engineers is that the regulatory compliance folks will not allow OSS or that the FDA will disapprove. There is plenty of evidence to the contrary, however, because the FDA hasn’t really rejected devices due solely to the use of OSS. The lack of OSS use in medical devices and healthcare IT circles in most cases likely stems from a lack of experience with OSS at the senior executive and regulatory compliance ranks within companies. This is a summary of a quick 10 step process that R&D groups can use to properly experiment with and include OSS in safety-critical systems."
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