Medical device technology has become so advanced and diverse, it is extremely challenging to identify and anticipate all risks. Risk analysis is a regulatory requirement in which a medical device manufacturer is to identify a complete, unbiased picture of all possible hazards that could potentially be created by a device and design plans to avoid, mitigate, or control these hazards. The science of risk analysis and documentation of a risk management plan must incorporate the objective identification of defects or failures along with the subjective determinations of likelihood, severity, and acceptable risk limits during the entire life cycle of the medical device. This audio conference will provide an overview of risk analysis for medical devices, including information on the various international regulations with which manufacturers must comply.
This audio conference will cover:
- Definitions of risk terminology
- Reasons for requirements for formal risk analysis plans
- Diversity of medical devices and various types of associated hazards
- Tools for risk analysis and establishing risk indices
- Objective versus subjective determinations for risk analysis
About the speaker:
Amy Wise, PhD received her doctorate from Baylor College of Medicine in Houston, TX in 1998 in Molecular and Human Genetics. She has been involved in the conduct of clinical trials for over seven years with a strong focus in medical device project management and clinical monitoring. She has served as the Project Manager on over 17 medical device studies, including cardiac stents, electrocardiology device, spinal implants for degenerative disc disease, auto immune diseases, gastroparesis, and peripheral vascular stents.
Who should attend?
- quality managers
- regulatory affairs
- quality compliance
- clinical or regulatory project managers
- production managers
- engineers
This audio conference is an introductory level presentation.
*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.