Link: https://www.iso.org/iso-13485-medical-devices.html
Description: WEBWho is ISO 13485 for? ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
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Link: https://www.iso.org/standard/59752.html
Description: WEBISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
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Link: https://en.wikipedia.org/wiki/ISO_13485
Description: WEBISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest …
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Link: https://advisera.com/13485academy/what-is-iso-13485/
Description: WEBApr 25, 2024 · ISO 13485 is an international standard that outlines the requirements for a Quality Management System in the medical device industry. This standard is specific to medical devices and covers the entire life cycle of a device, from design and development to production, installation, and servicing.
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Link: https://www.iso.org/obp/ui/
Description: WEBThis International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and...
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Link: https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100377.pdf
Description: WEBQuality management for medical devices. ISO 13485. ISO 13485, Medical devices –. Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.
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Link: https://www.iso.org/publication/PUB100422.html
Description: WEBSep 25, 2017 · Paper. ISO 13485:2016 – Medical devices – A practical guide has been authored by technical experts of ISO/TC 210. The handbook is intended to guide organizations in the development, implementation and maintenance of their quality management system in accordance with ISO 13485.
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Link: https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100422_preview.pdf
Description: WEBPublished in Switzerland. All organizations face challenges when developing or updating their qual-ity 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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Link: https://cdn.standards.iteh.ai/samples/59752/9ee40ab0ec6546f7b0703e5c7d96b5ad/ISO-13485-2016.pdf
Description: WEBISO/TC 210, Quality management and corresponding general aspects for medical devices. This secondthird edition ISO 13485 cancels and replaces the of second edition first (ISO 13485:19962003) and ISO/TR 14969:2004, which hashave …
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Link: https://www.bsigroup.com/en-US/medical-devices/Our-services/ISO-13485-Quality-Management/
Description: WEBEN 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 …
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