Insights · Standards

Standards articles.

Every article in our archive in Standards.

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.

#AAMI SW96#AAMI TIR57#FDA

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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.

#Primer

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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.

#Primer

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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.

#Primer

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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.

#Primer

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Standards· Jun 3, 2026

IEC 81001-5-1 vs AAMI SW96

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.

#Primer

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Standards· May 27, 2026

AAMI TIR57 vs TIR97 vs SW96

Compare AAMI TIR57, TIR97, and SW96: scope, lifecycle stage, FDA recognition, and how to stack them in a 2026-ready SPDF program.

#Primer

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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.

#Primer

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Standards· Apr 17, 2025

Medical Device Cybersecurity Traceability

Why traceability is the backbone of medical device cybersecurity: linking risks, requirements, controls, and tests into FDA-ready submission evidence.

#Primer

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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.

#Standards

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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.

#Standards

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Standards· Oct 20, 2024

GMP for Medical Device Cybersecurity

Updated November 10, 2024 In the medical device industry, Good Manufacturing Practices (GMP) form the foundation for ensuring the safety, effectiveness.

#Primer

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