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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 third edition of ISO 13485 cancels and replaces the second edition (ISO 13485:2003) and ISO/TR 14969:2004, which have been technically revised. It also incorporates the Technical Corrigendum ISO 13485:2003/Cor.1:2009 .
25 Μαΐ 2022 · Find the ISO 13485:2016 standard free online on ANSI’s website. Please follow the steps in this article to access the standard.
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.
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.
standard ISO 13485 to create a customer focus while consistently meeting customer and regulatory requirements. Our QMS encompasses all operations at our facilities.
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.
