[FREE WEBINAR] State of the Art: Building a Solid Foundation for your PER to Support IVDR Readiness
Click here to watch the webinar Key Takeaways: The importance of planning and preparation before you even begin to actually write the SOA The complete outline of the SOA literature […]
[FREE WEBINAR] Leveraging the MDR experience for IVDR: Tips for Successful Performance Evaluation and PMS/PMPF Processes
Click here to watch the webinar Who should watch? All regulatory, clinical, and scientific professionals who are tasked with the development, writing, review or approval of scientific manuscripts, reports, presentations, […]
Risk Benefit Analysis and Residual Risk are Key Components of ISO 14971:2019
Author: Nupur Srivastava, PhD | December 7, 2020 The International Organization for Standardization (ISO) 14971:2019 places more emphasis on the risk to benefit ratio of medical devices, asking manufacturers to show that their device is […]
