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 19 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
How JSP2 and MDS2 Fit Together for Medtech
JSP2 is a development framework, MDS2 is a procurement disclosure form. Here's how the two artifacts complement each other across the device lifecycle.
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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 vs AAMI SW96 Compared
IEC 81001-5-1 vs AAMI SW96 compared side-by-side: scope, lifecycle vs risk focus, FDA recognition, and which to anchor your Secure Product Development.
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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· Dec 4, 2025
Medical Device Cybersecurity Labeling
Learn how to get medical device cybersecurity labeling right with MDS2, JSP2, and FDA expectations - improving transparency, accountability, and patient.
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Standards· Apr 17, 2025
Medical Device Cybersecurity Traceability
Medical device cybersecurity traceability links risks, controls, and verifications throughout a device's lifecycle. Aligned with the FDA's Feb 3, 2026.
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Standards· Nov 17, 2024
IEC 80001-1 Explained: Medical Device Network Risk Management
IEC 80001-1 assigns risk-management responsibilities when medical devices connect to hospital IT networks. Roles, controls, and how it maps to FDA 2026 guidance.
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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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