Risk Management for Medical Devices Training Course
As medical devices continue to grow in complexity, effectively identifying and controlling risks has become more critical than ever to ensure patient safety.
In this course we explore key concepts of the ISO 14971 standard, providing you with a deep understanding of key requirements for risk management and how they integrate into other standards and regulations.
Whether you are new to medical devices or looking to strengthen your expertise, this course has everything you need to confidently implement ISO 14971.
Date: 09 – 12 June, 2025 (4 half days)
Time: 13:00 - 17:00 BST | 8:00 - 12:00 EST
RAC Credits: 12
In this course we explore key concepts of the ISO 14971 standard, providing you with a deep understanding of key requirements for risk management and how they integrate into other standards and regulations.
Whether you are new to medical devices or looking to strengthen your expertise, this course has everything you need to confidently implement ISO 14971.
Date: 09 – 12 June, 2025 (4 half days)
Time: 13:00 - 17:00 BST | 8:00 - 12:00 EST
RAC Credits: 12
What's included?
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Your own learning portal
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Course recordings
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Free 1-2-1 with the trainer
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Live sessions
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PDF materials
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Self paced modules
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Certificate of completion
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Access to a community
Learn with a community
Social learning is a powerful tool that enables individuals to learn from each other through observation, communication, and collaboration.
Using our community, people can more efficiently acquire new knowledge, skills, and behaviors.
Using our community, people can more efficiently acquire new knowledge, skills, and behaviors.
Assessments & Feedback
Assessments and feedback are essential components of the learning process, offering valuable insights into progress.
All of our courses use knowledge checks and practical peer learning throughout to reinforce understanding.
All of our courses use knowledge checks and practical peer learning throughout to reinforce understanding.
- Meet the trainer
Rod Beuzeval
Rod’s experience has involved providing regulatory strategy from product development to worldwide market registration, creation of technical documentation, implementation of full 13485 compliant QMS systems, standards compliance, clinical evaluations, risk management files, project management and remediation activities. Rod has also spent time working for a notified body, conducting audits against ISO 9001, ISO 13485, 21CFR820, MDSAP, cGMP and GDP.
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training expert.
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Frequently asked questions (FAQs)
Who should attend this course?
This course is ideal for professionals involved in the medical device industry, including those new to the field as well as experienced individuals looking to strengthen their expertise in risk management. Regulatory affairs specialists, quality assurance managers, design teams, Marketing and anyone involved in ensuring the safety of a medical device.
How does this course help in developing an effective risk management system?
This course provides detailed guidance on establishing processes and documentation necessary for an effective risk management system. Participants will learn to implement gold standard techniques for risk analysis, create comprehensive benefit-risk statements, and ensure their documentation meets regulatory expectations. This ensures a systematic approach to identifying, evaluating, and mitigating risks associated with medical devices.
Do you offer in-house training?
Absolutely! This course can be delivered virtually or on-site for corporate teams and can be tailored to your specific requirements. For details contact info@leapcompliance.com
Will I receive a certificate after the course?
After successful completion of this training, you will receive a digital certificate. This certificate can be used to showcase your risk management knowledge to employers and Notified Bodies.
