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ISO 13485:2016 - Quality Management Systems for Medical Devices
ISO 13485:2016 - Quality Management Systems for Medical Devices
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What You Will Learn In This Free Course
- Compare the revision of ISO 13485:2...
- List the main clauses of the ISO 13...
- Define important terminologies abou...
- Explain the purpose of other intern...
- Compare the revision of ISO 13485:2003 to ISO 13485:2016
- List the main clauses of the ISO 13485:2016 standard along with the requirements
- Define important terminologies about medical devices as per ISO 13485:2016
- Explain the purpose of other international and regulatory standards like ISO 14971 and FDA 21 CFR Part 820
- Compare ISO 13485 with FDA 21 CFR Part 820
- Describe how to manage the requirements about medical device files
- Illustrate how to assimilate work environment and contamination control requirements
- Describe how to manage the requirements about design and development
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Learner Reviews & Feedback For ISO 13485:2016 - Quality Management Systems for Medical Devices
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Learners Who Took This Course Also Enrolled In
- ISO 9001:2015 - Quality Management System (QMS)
- ISO 14971:2019 - Risk Management Application on Medical Devices
- Essentials of European Medical Device Regulations (EU MDR) - 2017/745
- ISO 14001:2015 - Environmental Management Systems (EMS)
- ISO 45001:2018 - Principles of Occupational Health and Safety Management Systems
- ISO 19011 Lead Auditor
- ISO/IEC 17025:2017 - Laboratory Management Systems
- 21 CFR Part 820 - Fundamentals of Quality System Regulation (QSR)