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Medical devices: The importance of using standards to demonstrate conformity

Standards have a critical role in regulatory compliance for medical device manufacturers. The webinar below analyses the intricate relationship between regulations and standards, emphasising the concept of ‘presumption of conformity’, which often allows manufacturers to use standards as evidence that their devices meet regulatory requirements.

Webinar: Why standards are the best way to demonstrate conformity to regulations

watch our webinar here

Free Whitepaper Downloads

1. Regulatory authorities around the world not only use standards to support their regulations but use different approaches to apply or recognise standards. Download this whitepaper today to learn about using standards to demonstrate conformance with regulatory requirements.

using standards to demonstrate conformity

2. In this whitepaper, we look to see how these standards co-exist and what developments are being discussed. The intent of this document is to provide insight into some of the differences and similarities between the standards, to allow organisations to understand how they can continue to work together for organisations that are part of the medical device supply chain, without undue burden to their systems.

the differences and similarities between iso 9001:2015 & iso 13485:2016

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