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ISO 14971:2019 - Risk Management Application on Medical Devices

Learn the fundamentals of the ISO 14971:2019 standard and its impact on the medical field in this free online course.

Publisher: Exoexcellence Consultants
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 which ISO updated in ISO 14971, an overview of ISO TR 24971 and how it helps implementing ISO 14971, as well as the risk management steps in the standard and impact of it in Europe.
ISO 14971:2019 - Risk Management Application on Medical Devices
  • Duration

    1.5-3 Hours
  • Students

  • Accreditation






View course modules


This free online interactive ISO training course enables a better understanding of the ISO 14971:2019 standard. It will help you to analyze the impact of ISO 14971:2019 on a medical device manufacturer’s decision-making process and empowers professionals to comprehend how the standard can enhance their medical devices business and associated risk management efforts. While taking this course, it is recommended that you know the basics about the ISO 13485 international standard on medical devices and quality assurance. The knowledge can be validated with Alison’s free online course on ISO 13485, any other formal training course on the standard or if you have experience with it in the medical device industry. This high-quality ISO guide comes with a unique self-paced approach of learning which can be accelerated based on your reading and assimilation appetite and enhances knowledge retention through practical activities.

This course is structured in a way to offer you an in-depth understanding of ISO 14971 and the influence it has on the conceptualization, design, production, and complete life cycle of a medical device. It will also provide you with exactly how ISO 14971:2019 links with the ISO standards 13485:2016, ISO/TR 24971:2020, and MDR 2017/745. In addition to the activities provided in the course, you will receive study reminders and transferable notes to help you learn and comprehend the content and be able to apply it in your daily work. This formal ISO training can be a great addition to your résumé, boost your confidence during job hunting and will enable you to discuss ISO 14971 during your interviews effectively and confidently.

After successful completion of the course which includes an online assessment, professionals can apply and implement risk management activities so that these can be deep-rooted within the processes of an organization. You can retake the online exams as many times as you want, which can keep the content fresh in your mind. This online ISO 14971 course is best for you if you are in a role involved in medical device design, production, and with any part of device life cycle. If you are a quality assurance (QA) professional, working in a Regulatory Affairs role or in manufacturing in the medical devices’ sector, this course will add important technical knowledge for your career. You should enrol in this comprehensive course if you are looking to get a job in any of the above roles in the healthcare sector and want to up-skill yourself in risk management.

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