FDA issued a compliance letter to a company distributing an uncleared Mobile App for reading urine analysis strips on May 21, 2013. The full text of this letter is on our warning letter page.
IEC 62304 and other Emerging Standards Impacting Medical Device Software
Being Agile & Yet Compliant
ISO 14971 SaMD Risk Management
Software Risk Management
Medical Device Cybersecurity
Software Verification
IEC 62366 Usability Process and Documentation
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