ISO 14971 and MDR – Regulatory Requirements for Risk Management
To ensure the quality and performance of medical devices throughout their entire product lifecycle, an effective risk management system is of paramount importance. Processes must be designed to be safe, errors must be detected in a timely manner, and risks must be minimized as much as possible.
To achieve this, you need a risk management process tailored to your company’s needs. This is the only way to ensure that risk management is not only compliant but also applied efficiently. We’ll show you how to successfully meet the regulatory requirements of Regulation (EU) 2017/745 for medical devices (MDR) and the ISO 14971 standard within your organization.
In this interactive seminar, you will learn how to implement and document a professional risk management processin accordance with ISO 14971. We will also address the most important interfaces with other processes in development and subsequent phases.
Numerous illustrative examples and practical tips will help you apply the requirements to your company and your products.
- Content
- Risk Management: Objectives and Benefits
- Regulatory Requirements (MDR 2017/745, IVDR 2017/746)
- Risk management process according to ISO 14971:2019
- Risk management plan
- Risk analysis
- Risk assessment
- Risk control
- Overall residual risk assessment
- Benefit-risk analysis
- Review of risk management
- Risk management file
- Risk management: Interfaces and data flows
- Usability (Usability Engineering)
- Product Development (Design Control)
- Clinical Evaluation
- Technical Documentation
- Post-Market Surveillance
- Excursions:
- Harmonized EN ISO 14971
- Risk Policy
- MDR 2017/745
- IVDR 2017/746
- Practical Exercises on Risk Analysis
- Your Benefits
- You will learn about the various regulatory and standard requirements for risk management according to EN ISO 14971 and the MDR:
- Regulation (EU) 2017/745 on medical devices (MDR)
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
- DIN EN ISO 14971:2022-04 (corresponds to EN ISO 14971:2019 + A11:2021)
- You will receive practical solutions for your company.
- You will learn how to effectively design a risk management system to control risks and capitalize on opportunities.
- You will be able to fully establish, structure, and review the risk management process.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Manufacturers of medical devices and in vitro diagnostic devices
- Risk managers and members of risk management teams
- Regulatory affairs managers
- Quality management representatives
- Auditors
