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Understanding ISO 14971: Comprehensive Guide to Risk Management for Medical Devices
Abstract ISO 14971 is one of the most widely accepted standards that offer a coherent process for managing medical device risks. This paper aims to evaluate the incidence of risks, regulatory provisions, and risks to patients concerning the entire lifecycle of a device. It also includes an extensive examination of procedures for assessing and controlling […]
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ISO 13485 Ensuring Quality and Safety in the Medical Device Industry
A Comprehensive Guide to Standards, Implementation, and Future Trends Introduction to ISO 13485 What is ISO 13485? ISO13485 is a worldwide standard made just for the quality management systems (QMS) of groups that work with medical devices. From conception, design, and production to servicing and decommissioning, ISO 13485 ensures that quality and safety remain important […]
