Learn the fundamentals of the ISO 14971:2019 standard and its impact on the medical field in this free online course. In this free online ISO certification, you will learn the risk management process in the manufacturing environment of medical devices. You will understand how ISO 14971 can help your organization comply with regulations and learn the new annexes, terms, and clauses in the updated ISO 14971 standard. Learn about ISO TR 24971 and how it helps in implementing ISO 14971. Also, learn about risk management in the standard and its impact across Europe.
| College | Alison |
| Course ID | 187890 |
| Course Type | Online Learning |
| Course Qualification | CPD Certificate |
| Course Duration | 1.5-3 hours |
| Course Fee | Free |
| Entry Requirements | Like all courses on the Alison Free Learning platform this is a free, CPD-accredited course. A Graduate can choose to buy a certificate or diploma upon successful completion of a course, but this is not required or necessary. At Alison we believe that free education, more than anything, has the power to break through boundaries and transform lives. Alison is the world’s largest free online empowerment platform for education and skills training, offering over 5000 CPD accredited courses and a range of impactful career development tools. It is a for-profit social enterprise dedicated to making it possible for anyone, to study anything, anywhere, at any time, for free online, at any subject level. Through our mission, we are a catalyst for positive social change, creating opportunity, prosperity, and equality for everyone. |
| Career Path | In This Free Course, You Will Learn How To • 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 |
| Course Code | 4064 |
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