Insights · Standards

Standards articles.

Every article in our archive in Standards.

Standards· Nov 17, 2024

IEC 80001-1: Enhancing Medical Device Cybersecurity

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

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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 robust protection in the evolving digital healthcare landscape..

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Standards· Oct 20, 2024

Medical Device Cybersecurity and ISO 9001

Discover the crucial intersection between medical device cybersecurity and ISO 9001 in this insightful article.

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Standards· Oct 20, 2024

IEC 62304 and Medical Device Cybersecurity

Learn how IEC 62304 supports medical device cybersecurity - secure software lifecycle, risk controls, and FDA-ready evidence to speed submissions and reduce risk.

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Standards· Oct 20, 2024

ISO 13485 and Medical Device Cybersecurity

Updated April 17, 2025 ISO 13485, a globally recognized standard for quality management systems (QMS) in the medical device industry, is vital for ensuring medical devices' safety, effectiveness, and quality. It provides a framework for organizations designing, developing, producing, installing, and

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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 bodies. The Manufacturer Disclosure Statement for Medical Device Security (MDS²) plays a pivotal role in addressing these concerns by providing a s

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Standards· Feb 25, 2024

IEC 81001-5-1: 2021 and Medical Device Security

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

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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.

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Standards· Feb 11, 2024

ISO 27001 and Medical Device Cybersecurity

ISO 27001 strengthens medical device cybersecurity, but it must be paired with patient safety standards and FDA guidance to protect patients fully.

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Standards· Jan 22, 2024

AAMI TIR57 Risk Management for Medical Devices

A practical guide to AAMI TIR57 (R2023) and how it supports FDA’s Feb 2026 cybersecurity guidance - risk analysis, controls, and evidence.

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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.

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