“Guidance for Industry and FDA Reviewers/Staff In Vitro Diagnostic Fibrin Monomer Paracoagulation Test”
This document was issued on April 27, 1999 and internal to the document it indicates that this is a draft guidance.
It has a section on software that states that validation information and a software certification statement should be included in the submission.
ISO13485:2016 ISO 13485 Internal Audit(or) Training Course (Live, 3-day)
IEC 62304 and other Emerging Standards Impacting Medical Device Software (Live, 3-day)
Being Agile & Yet CompliantISO 14971 SaMD Risk Management
Software Risk Management
Medical Device Cybersecurity
Software Verification
IEC 62366 Usability Process and Documentation
Or just email training@softwarecpr.com for more info.
