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

Read article

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

Read article

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

Read article

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

Read article

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

Read article

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.

#Primer

Read article

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.

#Primer

Read article

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

Read article

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.

#Primer

Read article

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

Read article

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

Read article

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.

#Primer

Read article

Ready when you are

Get FDA cleared without the cybersecurity headaches.

30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ FDA submissions.