Are You Ready for ISO 14971:2019? – Webinar Recording/Transcript
Are You Ready for ISO 14971:2019?: Manage Changes to Your Risk Management Systems
You have until December 2022 to fully comply with ISO 14971:2019. If you’re not ready to implement the revised requirements in ISO 14971:2019 and EN ISO 14971:2019 within your risk management system, your devices may not be compliant.
How will ISO 14971:2019 impact you as a manufacturer? What will you need to do differently? Will you need to rethink the way you’ve been doing risk management?
You must be ready to implement the revised requirements in ISO 14971:2019 and EN ISO 14971:2019 within your risk management system by December 2022.
This presentation — given by Christine “Tina” Krenc, a member of ISO/TC 210 JWG1, which developed ISO 14971 — is your opportunity to get best practices and guidance to meet the revised requirements. You’ll be able to optimize your risk management system and stay compliant.
- Impact of ISO 14971:2019 on your operations
- Best practices to meet ISO 14971:2019’s revised requirements
- How regulators and auditors will look at things differently
- Procedural changes should you make in addition to changing the references in your SOPs
- Rethink the way you’ve been doing risk management
Come away with an understanding of far more than just the differences between old and new. You’ll be equipped to manage any required changes to your risk management system, so you can stay compliant.
Meet Your Presenter:
Christine “Tina” Krenc is the principal consultant for KTA Compliance Consulting. She has more 36 years of medical device experience in a variety of organizations and functions including IVDs, software, hardware, combination products and implantable medical devices. Ms. Krenc has led employees in research and development, clinical research and operations technical support, and has over 25 years of quality assurance experience in multiple quality organizations. She serves as a member of ISO/TC 210 JWG1, which developed ISO 14971 Medical Devices – Application of Risk Management to Medical Devices, and the accompanying Guidance TR 24971 – Medical Devices Guidance on the application of ISO 14971 for medical devices.
Who Will Benefit:
- Quality Personnel
- Regulatory Personnel
- Engineering Personnel
- R&D Personnel on Market Technical Support
- Post-market Surveillance Personnel