The 2 main goals of MDR are to ensure that medical devices on the EU market deliver the claimed clinical benefit and are safe to use. With that in mind, risk management has become the backbone of manufacturers' operations, covering every aspect of medical device technical documentation. State of the art in risk management is ISO 14971. Manufacturers who implement ISO 14971 are on the right track toward MDR compliance and, more importantly, to put devices on the market with risks mitigated as much as possible.
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There are multiple risk analysis techniques and multiple approaches to risk management. MDR sets the framework, and ISO 14971 provides tools for professionals to build a robust, effective and compliant risk management file. Other major standards also interact with ISO 14971; it is crucial to learn how to create an effective risk management system using other relevant standards to your benefit.
Key Topics Covered:
- Deep dive into the process of risk management
- How to develop a risk management control table
- What are risk analysis techniques and how to use them
- Difference between FMEA and ISO 14971
- How to quantify risks & benefits
- Most common issues
By the end of this training, participants will be able to:
- Understand details of the risk management process
- Distinguish between an FMEA and ISO 149741
- Build and maintain a risk management table
- Quantify risks and benefits
- How to build a compliant risk management file
Target Audience: Regulatory Affairs, Quality Management, Packaging Engineers, Product Development, Sustainability Chain and Compliance Managers
Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH
Auditors
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Irenej Polacek
Moderator
Technica file reviewer / Auditor
A graduate biomedical engineer specialising in prosthetics, orthotics, orthopaedics, and custom-made cranio-maxillo-facial implants, he worked at CEIT Biomedical Engineering during his PhD. He gained extensive experience in dental medical devices as a product specialist at FONA Dental, collaborating with the design team and end users. He then joined 3EC International, a Slovak notified body, where he spent four years as a technical file reviewer and lead auditor, completing training in MDR, risk management, usability, PMS, and external auditing. Later, at DQS, he earned certifications from their comprehensive MDR, ISO 13485, and MDSAP conformity assessment training.
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