A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!
Bringing the Clinical Perspective into ISO 14971 Risk Management Discussions
Upcoming Courses
The clinical perspective is crucial to understanding risk and implementing effective decision-making in the risk management of medical devices. ISO 14971 is an international standard used by companies around the world as a basis for developing a risk management process for analyzing the risk associated with a medical device. Risk management for medical devices is typically handled by engineers responsible for designing and building a product and can have a tendency to focus on the mechanical risks instead of the clinical risks. A clinician needs to be available to discuss those risks in ways that are understandable to those outside of patient care, while understanding how the engineers discuss and view the device.
- Explain the requirements of ISO 14971
- Discuss how to predict severity and probability of risks based on clinical data
- Describe the product lifecycle and how to use clinical data to guide risk mitigation
- Clinical Data Specialists/Analysts
- Clinical Data Managers
- Clinical Operations Professionals
- Clinical Project Managers
- Clinical Safety Experts
- Production, Quality, and Safety Engineers
Joy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.P.S.
Click here for complete trainer biographies
$695
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-15-082-L01-P. Released: 12/15.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
