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Whitepaper
Medical Devices
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.
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Use of standards to support regulations for medical devices
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European harmonized standards
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US FDA recognized standards
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UK designated standards
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Standards and the state of the art
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Monitoring standards development and implementing new or revised standards
BSI is your partner for regulatory compliance
Discover our medical device standards and certification services below:
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Compliance Navigator
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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BSI Knowledge
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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Medical Devices
Our mission is to ensure patient safety whilst supporting timely market access to medical technology in a sustainable manner
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Speak to the Compliance Navigator team today
Transform your document management process and stay ahead of medtech regulatory updates. Talk with our experts today and arrange a free trial.
