ISO 14971:2019 - Risk Management Application on Medical Devices (Free Online Course With Certificate)
Online USA
Course
DURATION
3 hours
LANGUAGES
English
PACE
Full time, Part time
APPLICATION DEADLINE
EARLIEST START DATE
TUITION FEES
STUDY FORMAT
Distance Learning
* free course
Key Summary
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.
This Free Online Course Includes:
- 1.5-3 Hours of Learning
- CPD Accreditation
- Final Assessment
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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 device business and associated risk management efforts. While taking this course, it is recommended that you know the basics of 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 to 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 offers 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 any part of the device life cycle. If you are a quality assurance (QA) professional, working in a Regulatory Affairs role or manufacturing in the medical devices sector, this course will add important technical knowledge to 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.
Module 1
Fundamentals of Medical Devices' Risk Management Standard
This module introduces you to the ISO 14971:2019 standard. You will learn about the clauses and annexes that were changed, updated, or added. Furthermore, you will know why the standard was revised and how it aligns with other standards. In addition, the module will provide you with an overview of the changes made in the standard and its technical report, i.e., ISO TR 24971. Also, the module will give you a collective explanation of the main changes in the standard and its technical report.
Module 2
Essentials of ISO 14971 & ISO TR 24971
In this module, you will learn the composition of ISO 14971. You will know the specific explanations in the standard ISO 14971:2019 and its technical report. This module separately explains the standard and its technical report in two different topics with brief and precise explanations. You will also learn the six risk management process steps in ISO 14971:2019, which are of great importance in industrial manufacturing processes. Lastly, the module covers the impact of ISO 14971:2019 in Europe.
Module 3
Course assessment
What You Will Learn In This Free Course
- 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 standards.
- 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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