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14 Απρ 2020 · For example, the ISO 13485:2016 standard in PDF format is not available for free download – you can access ISO 13485 in read-only (text) format for free or, if needed, purchase the ISO 13485 PDF on the ISO website.
This 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...
ISO 13485 is the internationally recognized standard for quality management systems in the design and manufacture of medical devices. It outlines specific requirements that help organizations ensure their medical devices meet both customer and regulatory demands for safety and efficacy.
25 Μαΐ 2022 · The American National Standards Institute (ANSI) has an online view-only system where you can access ISO 13485 for free. On page 2 on the website, you will find the ISO 13485:2016 standard. To open and view the file, you will need either Adobe Reader or FileOpen browser plugins.
ISO 13485:redline:2016(E) Introduction 0.1 General This International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.
25 Σεπ 2017 · A free brochure with tips for getting started with ISO 13485, requirements for quality management systems related to medical devices.
The International Standard ISO 13485:2016 defines criteria for a Quality Management System for Medical Device Manufacturing; this ensures that all medical devices meet proper regulatory compliance laws and customer needs.
