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ISO 13485:2016 - Quality Management Systems for Medical Devices

ISO 13485:2016 - Quality Management Systems for Medical Devices

Learn about the requirements of Quality Management Systems for Medical Device organizations and its regulatory aspects.

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Course Highlights

  • 3 Hours of E-learning content, tests etc

  • Earn a digital Certificate and become an Allison Graduate on scoring above 80% in assessments

  • Update yourself with latest ISO standard

  • Trainer & Facilitator-S.M. Waqas Imam

Mode of learning: Online self study

Course Overview

What are the course deliverables ?
  • Compare the revision of ISO 13485:2003 to ISO 13485:2016

  • ist 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

More about this course
  • This free online ISO 13485:2016 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 and definitions related to stakeholders, product, QMS, Risk and Sterilization, and more.

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    Dr.Shubham painoli

    It was a wonderful experience. It was so much required in my current job role and this knowledgw really helped me a lot by providing company iso certification in medical devices. Stronglybrecommended.
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