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 12 of 15 articles in Standards · Page 1 of 2
Standards· Jul 7, 2026
How SPDF Maps to IEC 81001-5-1 Activities
A phase-by-phase mapping of the FDA's SPDF onto IEC 81001-5-1 activities, so dual FDA + EU submissions produce one artifact set instead of two.
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Standards· Jul 7, 2026
IEC 81001-5-1 vs IEC 62304 for Medical Devices
IEC 62304 governs the software lifecycle. IEC 81001-5-1 adds security activities on top.
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Standards· Jul 7, 2026
JSP2 vs SPDF vs IEC 81001-5-1: Framework Pick
The FDA lists JSP2, SPDF, IEC 81001-5-1, and ISA/IEC 62443-4-1 as acceptable cybersecurity frameworks. Here's how to actually pick one for your submission.
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Standards· Jun 3, 2026
IEC 81001-5-1: Secure Lifecycle Rules
IEC 81001-5-1 explained: scope, mapping to AAMI SW96 and TIR57, what the FDA recognizes, and what evidence each standard produces for submissions.
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Standards· May 27, 2026
AAMI TIR57 vs TIR97 vs SW96
Medical device cybersecurity relies on AAMI TIR57, TIR97, and SW96. Understand their applications, FDA recognition, and how to use them for compliance.
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Standards· Apr 17, 2025
Medical Device Traceability Matrix: Guide
A medical device traceability matrix links threats to security risks, requirements, controls, and verification evidence for FDA premarket review.
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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
GMP and Medical Device Cybersecurity Compliance
GMP Cybersecurity Compliance for medical device manufacturers: what the FDA expects in 2026, gaps that trigger deficiencies, and evidence to prepare.
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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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