
ISO 14971:2019 - Aplicação de gerenciamento de riscos em dispositivos médicos
ISO 14971:2019 - Aplicação de gerenciamento de riscos em dispositivos médicos
What You Will Learn In This Free Course
- Discuss the reasons to update the I...
- Describe how the ISO 14971:2019 sta...
- Outline the changes made in ISO 149...
- List the new terms and definitions ...
- Discuss the reasons to update the ISO 14971:2019 standard
- Describe how the ISO 14971:2019 standard corresponds with other standards
- Outline the changes made in ISO 14971:2019 and ISO TR 24971
- List the new terms and definitions which ISO added in the ISO 14971:2019 standard
- Explain the annexes added in the ISO 14971:2019 and ISO TR 24971 standard
- Discuss the composition of the ISO 14971 standard
- Outline the changes in the ISO 14971 standard
- List the specific changes made in the revised version of the ISO 14971 standard
- Summarize the annexes, modifications, and clauses in the technical report of the ISO 14971 standard
- List the risk management process steps in the ISO 14971:2019 standard
- Explain the impact of ISO 14971:2019 in Europe
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Get your PlanLearners Who Took This Course Also Enrolled In
- ISO 13485:2016 - Quality Management Systems for Medical Devices
- Essentials of European Medical Device Regulations (EU MDR) - 2017/745
- ISO 9001:2015 - Quality Management System (QMS)
- 21 CFR Part 820 - Fundamentals of Quality System Regulation (QSR)
- Fundamentals of US FDA Medical Device Submission Process
- Fundamentals of EU IVDR Regulations for In-Vitro Medical Devices
- ISO 14001:2015 - Environmental Management Systems (EMS)
- ISO 45001:2018 - Principles of Occupational Health and Safety Management Systems