![]() ![]() This makes it more prescriptive in nature and requires a more thoroughly documented QMS. Therefore, ISO 13485 includes particular requirements for organizations involved in the life-cycle of medical devices and excludes some of the requirements of ISO 9001 that are not appropriate. While ISO 13485 is based on the ISO 9001 process model concepts of ‘Plan, Do, Check, Act’, it is designed for regulatory compliance. ISO 13485 is a stand-alone QMS standard, based on ISO 9001:2008, which has been superseded by ISO 9001:2015. ![]() ISO 13485 requires organizations to implement these processes in accordance with identified applicable regulatory requirements for the markets they intend to operate in. Patient safety is at the very heart of ISO 13485, with its main purpose being to ensure the consistent design, development, production, storage and distribution, installation or servicing and disposal of medical devices. EN ISO 13485 is the medical device industry's quality management system (QMS) harmonized standard written to specify requirements for an organization to design and implement a quality management system to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ![]()
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For example, showing off a cool stunt, introducing a new mod you've developed, etc.įor posts, if not obvious, you should submit the link as a self-post and include an explanation. Submissions with a specific purpose are not considered self-promotion. This includes but is not limited to YouTube content, blogs/articles, referral links, etc. Be respectful, or you may be banned.ĭo not link or discuss pirated mods, games, or piracy websites. Toxic and aggressive behavior will not be tolerated.ĭo not be rude to any other user. Keep discussions civil, mature and friendly. ![]() No offensive behavior or inappropriate content. 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