Udemy - Medical Devices Quality Management System - ISO 13485 - 2016

[ FreeCourseWeb.com ] Medical Devices Quality Management System - ISO 13485:2016



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MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz, 2 Ch

Genre: eLearning | Language: English + .srt | Duration: 9 lectures (1h 31m) | Size: 513.9 MB

Awareness and Application for the requirements of ISO 13485:2016 for Medical Device Development and QMS

What you'll learn:

How ISO 13485 requirements apply to medical device companies

Requirements of the ISO 13485:2016 standard

The importance of implementing a Quality Management System per ISO 13485:2016



Requirements

No specific prior knowledge is required

Familiarity with quality management systems is helpful

A general understanding of medical device life-cycle is useful

Owning the ISO 13485:2016 standard is optional but recommended



Description

The ISO 13485:2016 standard specifies requirements for the Medical Device Development and Quality Management System (QMS) that should be used by medical device-related companies.



Having a proper QMS in place is essential for medical device-related companies. Global regulatory requirements emphasise this and make it mandatory for such standards to be adhered to by companies worldwide.



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