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 10 of 10 articles tagged Standards
FDA· Apr 10, 2026
ISO 27001 & SOC 2 vs FDA Medical Device
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 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
IEC 62304 and Medical Device Cybersecurity
How IEC 62304 supports medical device cybersecurity: secure software lifecycle, risk controls, and FDA-ready evidence to speed premarket submissions.
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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
Updated November 16, 2024 The cybersecurity of medical devices has emerged as a critical concern for manufacturers, healthcare providers, and regulatory.
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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
Learn how ISO 14971 risk management applies to medical device cybersecurity - identify cyber hazards, control residual risk, and align with FDA. Aligned with.
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Standards· Jan 18, 2024
ISO 14971 + AAMI TIR57: The Connection
This article discusses the relationship between ISO 14971 and AAMI TIR57 / ANSI/AAMI SW96:2023, and how they help address risks in the production and use of medical devices.
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