Αποτελέσματα Αναζήτησης
25 Μαρ 2016 · ISO 13485:2016 for medical device - Overview presentation.Full course at: http://www.iso-13485-2016.com
In this video you will learn about the structure, principles and clauses of ISO 13485:2016.
7 Ιαν 2019 · Best ISO 13485:2016 Starter Video [For Medical Devices] Easy Medical Device - https://easymedicaldevice.com is a blog to learn about the Medical Device Regulations and Standards.Buy ISO 13485...
Our turnkey quality management system for compliance with ISO 13485:2016 includes all of the standard operating procedures (SOPs) required by the standard and 21 CFR 820, 21 CFR 803, and 21 CFR 806 for the FDA. It also includes procedures for Canadian Medical Device Licensing and European CE Marking.
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 Σεπ 2017 · 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.
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.
