![]() ![]() They are usually paper-based, or the better ones PDF-based and all are costly and cumbersome. QMS solutions for small businesses or companies, much less startups, are few and far between. The following infographic offers a summary of these changes. The ISO 13485 revision includes significant changes in a number of important areas. It focuses on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system. The revised standard ISO 13485:2016 was published on 1st March 2016. The world’s most popular standard for medical device quality management has been revised for the first time since 2003: Medical Devices – Quality Management System – Requirements for Regulatory Purposes. ![]() Medical Devices – Quality Management System – Requirements for Regulatory Purposes
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