![]() ![]() In this handbook, advice to guide understanding of ISO 13485 and its application is given by first listing the full text of ISO 13485, followed by the intent of that section and relevant guidance. It is expected that you have basic practical experience with QMS and the applicable regulatory requirements within the medical devices sector to effectively understand the guidance provided. Therefore, it is broken up into the sections outlined in the contents in line with the clause structure of ISO 13485. It is not expected that you will sit down and read this handbook in one sitting, but that you might use it as a reference when questions come up about specific requirements. All organizations face challenges when developing or updating their quality management system (QMS) and it is hoped that this handbook will be used to provide additional insight and understanding of the requirements in ISO 13485 1), Medical devices – Quality management systems – Requirements for regulatory purposes.
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