Standards· Jul 21, 2026
AAMI SW96 vs TIR57: Did SW96 Replace It?
AAMI SW96 didn't formally replace TIR57, but SW96 is now the FDA-recognized normative standard. Here's what changed and what the FDA expects in 2026.
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Showing 9 of 9 articles tagged Standards
FDA· Apr 10, 2026
ISO 27001 & SOC 2 vs FDA Medical Device Rules
Why ISO 27001 and SOC 2 don't satisfy FDA medical device cybersecurity: the gaps in Section 524B evidence and what reviewers require instead.
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Standards· Nov 17, 2024
IEC 80001-1: Hospital Network Risk Management Explained
IEC 80001-1 defines how hospitals manage risk when medical devices join IT networks: roles, key properties, and what manufacturers must supply for compliance.
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Standards· Oct 28, 2024
MDCG 2019-16 & MedTech Cybersecurity
Explore the implications of MDCG 2019-16 on medical device cybersecurity, highlighting key guidelines, industry challenges, and strategies for ensuring.
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Standards· Oct 20, 2024
ISO 13485 and Medical Device Cybersecurity
How ISO 13485 quality management underpins medical device cybersecurity, and what FDA reviewers expect to see linked to your QMS in a 524B submission.
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Standards· Apr 7, 2024
The Role of MDS² in Medical Device Cybersecurity
MDS2 form explained: what HIMSS/NEMA HN 1-2019 requires, who completes it, how hospitals use it, common mistakes, and how it relates to SBOM and FDA rules.
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Standards· Feb 25, 2024
IEC 81001-5-1 & Medical Device Security
IEC 81001-5-1 defines requirements for integrating security into medical device software development. Learn how this standard ensures secure products.
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Risk· Jan 18, 2024
ISO 14971 Risk Management for Medical Device Security
How ISO 14971 risk management applies to device cybersecurity: identify cyber hazards, control residual risk, and align the file with FDA expectations.
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Standards· Jan 18, 2024
ISO 14971 + AAMI TIR57: The Connection
AAMI TIR57 adapts ISO 14971 to security risk management. Learn what the TIR covers, how ANSI/AAMI SW96 extends it, and what the FDA expects in 2026.
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