Using Standards to Demonstrate Conformity

Standards provide a voluntary means of demonstrating conformance

The application of standards in the medical devices sector has undoubtedly been accelerated by their use to support regulation.

Discover our medical device standards and certification services below:

A digital platform transforming how medical device and IVD device manufacturers manage their regulatory documents to save time and reduce risk.

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Deliver quality, improve safety and stay compliant with access to BSI’s healthcare standards. Embed best practice with a company-wide subscription.

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Our mission is to ensure patient safety whilst supporting timely market access to medical technology in a sustainable manner

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Insights & Media

Ageing Population: A Catalyst for Healthcare Innovation

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Annex XVI - Devices Without an Intended Medical Purpose

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EU MDR – Post Market Clinical Follow-Up

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Medical Device Lifetime

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Transform your document management process and stay ahead of medtech regulatory updates. Talk with our experts today and arrange a free trial.