Standards guides
The standards behind device software, explained from the committee side
I served on the teams that developed IEC 62304:2006/AMD1:2015 and ANSI/AAMI SW91:2018, and I've been a subject-matter reviewer for IEC 82304-1 and AAMI TIR80002-3. These guides cover what each standard asks for and where teams most often fall short.
IEC 62304
IEC 62304: the medical device software lifecycle
Software lifecycle processes, safety classes, SOUP and legacy software.
ISO 14971
ISO 14971: risk management for medical devices
Risk management across the device lifecycle, and how software fits in.
IEC 62366-1
IEC 62366-1: usability engineering for medical devices
Usability engineering, use errors and summative evaluation.
IEC 82304-1
IEC 82304-1: health software product safety
Product-level safety and security for standalone health software.
AAMI TIR57 and cybersecurity
Medical device cybersecurity: AAMI TIR57, SW96 and FDA expectations
Security risk management, SBOMs and FDA premarket cybersecurity.
QMSR (21 CFR 820)
The QMSR: FDA's quality system regulation built on ISO 13485
FDA's quality system regulation, now aligned with ISO 13485:2016.
FDA software guidance
FDA guidance for device software: what applies to your submission
The FDA guidance documents that shape a software submission.