In this free online course learn about the requirements of Quality Management Systems for Medical Device organizations and its regulatory aspects. This free online ISO 13485 certification training course will teach you about quality management systems for medical devices. You will study the ISO 13485:2016 standard, learn how it was developed, and look into the practical steps to company certification on ISO 13485. You will cover the types of available personal certifications and look closely at standard terminologies related to stakeholders, product, QMS, Risk and Sterilization, and more!
| Course Category | Quality Management, Business |
| 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 • 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 |
| Course Code | 1619 |
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