ISO 14971 – Medical Devices
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ISO 14971:2019 provides internationally recognized methods to reduce risk for all stakeholders. We will support you in ensuring that your medical device is compliant with EU Regulations and in bringing your medical device to the global market efficiently and safely by adopting this standard early in the planning process
What is ISO 14971?
Application of risk management to medical devices is a voluntary standard for the application of risk management to medical devices. "Voluntary standards do not replace national laws, with which standards' users are understood to comply and which take precedence" over voluntary standards such as ISO 13485 and ISO 14971. The ISO Technical Committee responsible for the maintenance of this standard is ISO/ TC 210 working with IEC/SC62A through Joint Working Group one (JWG1).
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