Risk Management Course
Risk Management Training Course
Get to Know EN ISO 14971 and Help Improve Your Regulatory Compliance
This intensive one-day course will provide the knowledge needed to understand EN ISO 14971 in the context of medical device risk management.
You will be taken through the complete set of regulatory expectations about active and non-active sterile devices, demonstrating how risk management relates to the requirements of MDR and UK MDR 2002. You will be ready to implement risk management procedures that ensure your medical devices are safe and maintain a high level of performance.
- Understand the relationship between UK MDR 2002/MDR and EN ISO 14971.
- Explain the role of risk management during the product lifecycle.
- Identify and understand the key requirements of EN ISO 14971.
- Identify and prepare key pieces of risk management documentation.
- Explain the key deliverables that comprise a complete risk management file.
Learning Outcomes
At the end of this course, participants will be able to:
Who Should Attend?
This course will apply to any people involved in Compliance, Design and Quality Assurance
- Regulatory and Quality Managers.
- Design and Development Engineers
- Project Managers engaged with compliance for medical devices.
- Quality System personnel are responsible for maintaining documentation related to risk.
Introduction to EN ISO 14971
Delve into the standard’s principles, goals, and perspective on an international scale. Includes an incident that frames the overview, a sequence of learning, and a brief introduction quiz.
Creating a Risk Management Plan
Understand the steps to writing a compliant risk management plan via examples referenced to sterile and active medical devices. Includes best practice guidance and brief assessments to support learning.
Effective Risk Analysis (FMEA)
Gain practical knowledge of how to identify hazards, complete FMEA, and document your findings. Includes knowledge of types of FMEA and their relationships to other classes of medical devices
Write a Risk Management Report
Develop an understanding of how to develop the final report and risk management file, ensuring that all aspects and supporting documentation are accounted for.
Conclusion & Test
Summarise learning highlights, undertake the final test, and consider the skills learnt throughout the course.
Training Format
To best ensure that the course is presented in accessible and flexible formats, MDSSPRO can present this training in 2 formats: online or onsite.
Online Interactive Course - £400 per person
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- small groups of 5 persons minimum and pre-recorded for smaller groups with tutor support
- Real-time Q&A and personal support
- Interactive exercises and case studies
- Certificate of completion upon final assessment and test completion
On-Site Customised Training
This course can be delivered at your business location and designed for your specific devices and regulatory requirements.
Please email admin@mdsspro.com for further information or a quote.
All courses are designed to be engaging and interactive and provide opportunities for hands-on activities (where available) and/or to facilitate real-life experiences with case-based discussions – keeping learners engaged and feeling confident to engage in their learning.
Let’s Build Compliance Confidence Together
MDSSPRO will work closely with you to increase your regulatory understanding and provide you with evidence of fully complying with EN ISO 14971. We aim to give you the knowledge, documents and confidence to deal with risk management at any stage of your device’s life cycle.
