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Products that are used to diagnose, prevent, or treat medical conditions are called medical devices. Medical device quality management systems must adhere to ISO 13485:2016 to ensure their safety and effectiveness. In the meantime, ISO 22313:2020 offers advice on how to set up and use a business continuity management system for unforeseen disruptions. Even though it is not specific to the medical device industry, it is essential for it to have a solid business continuity plan in order to continue providing essential medical devices in times of emergency. Organizations can ensure a comprehensive and efficient plan for managing the impact of disruptions on their business and their ability to provide safe and effective medical devices by implementing ISO 22313:2020
The most recent version of the international standard for business continuity management systems, known as ISO 22313:2020, released in December 2020. It provides updated guidance to assist businesses in preparing for and responding to unexpected disruptions and builds on previous standard versions. The standard is applicable to businesses of all sizes and sectors and was developed with input from experts, organizations, and government agencies worldwide. By providing a framework for developing and implementing a business continuity management system, it aims to assist businesses in reducing challenges and risks
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