Tagged · Standards

Standards articles.

Every article in our archive tagged 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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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.

#FDA#Standards

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Standards· Nov 17, 2024

IEC 80001-1: Medical Device Cybersecurity in Networks

Explore the intricacies of IEC 80001-1 and discover how this crucial standard enhances cybersecurity for medical devices.

#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

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.

#Standards

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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.

#Standards

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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

Discover the latest standards for medical devices with IEC 81001-5-1: 2021.

#Standards

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Standards· Feb 16, 2024

IMDRF: Harmonizing Med Device Regulations

Discover how the International Medical Device Regulators Forum (IMDRF) is working towards harmonizing global regulations for medical devices.

#Standards

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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.

#Risk#Standards

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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, and how they help address risks in the production and use of medical devices.

#Standards

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