Insights · Standards

Standards articles.

Every article in our archive in Standards.

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 21, 2024

OpenSSF for Medical Devices: 2026 Best Practices

OpenSSF for Medical Devices for medical devices: step-by-step practices, FDA-aligned documentation, and pitfalls to avoid in 2026 submissions.

#Primer

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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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Standards· Jan 19, 2024

Conducting a Medical Device Security Audit

Step-by-step guide for medical device manufacturers to run a cybersecurity audit: scope, threat modeling, SBOM review, testing, and FDA-aligned documentation.

#Audits#Quality

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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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