The MDR and IVDR regulations in EU, as well as requirements in other markets, such as the US (FDA), require risk analysis for all medical devices and in vitro diagnostic devices throughout the entire product lifecycle. The ISO 14971:2019 standard helps manufacturers and other stake holders in the medical device sector establish the structure, methods and ways of working needed to carry out and document risk management, control and follow-up. Learn to apply, in practice, this process oriented standard that guides you to patient- and user-safe products. The course will mix theory and practical sessions.
Gain a foundational understanding of the standard that helps you meet regulatory requirements, create safer products, prevent costly errors and strengthen quality across the entire organization.
Programme
- Risk management and risk analysis: clarifying the concepts
- Key definitions such as:
- Safety
- Risk
- Hazard
- Hazardous situation
- Etc.
- Management responsibility
- Risk management plan
- Risk analysis and risk evaluation
- Risk control and risk acceptance
- Hazard identification and hazardous situations
- Identifying causes, characteristics and intended use
- Risk management methods: Fault Tree Analysis (FTA) and FMEA
- Risk management report
Related standards
We will also briefly touch base on many other standards that are linked to ISO 14971, such as IEC 62366-1 (usability), IEC 81001-5-1 (cybersecurity), IEC 60601-series etc.
Who is the training for?
The training is primarily aimed at those who currently work, or will work, with risk management of medical devices in accordance with ISO 14971, or who otherwise contribute to product development and life cycle management at the company. But it is also useful if you work as a supplier, contract manufacturer or healthcare provider. All types of roles that participate in risk management can join the course.
Course Objective
After completing this course, participants will understand the principles and requirements of ISO 14971:2019 and be able to contribute effectively to the risk management of medical devices, from hazard identification and risk analysis to risk control, evaluation and lifecycle follow-up.
Please note:
Intertek operates under strict standards of independence, impartiality, and integrity. Read more about how we work here: https://www.intertek.com/about/compliance-governance/