Safe and effective medical device products uniquely depend upon a product development process of ongoing clinical interaction and feedback from and about the user, the environment and the patient.
TORONTO (PRWEB) April 02, 2019
The live session taking place on Tuesday, April 23, 2019 at 1pm EDT will provide insight into the connectivity between product risk management (ISO 14971) and the clinical risk management process (ISO 14155) and the use of eClinical platforms in supporting this process.
With increasing global regulation and reimbursement challenges faced by medical device companies, it is imperative for clinical trials to be strategically planned, well-designed, cost-effective, efficient and to be of high-quality. Safe and effective medical device products uniquely depend upon a product development process of ongoing clinical interaction and feedback from and about the user, the environment and the patient.
While human factors studies help inform design improvements early in the development process, clinical trial data and especially adverse events reporting throughout the lifecycle of a product is essential. Adverse events and related data can provide specific information on possible user errors or product issues (manufacturing or design) that can be addressed through immediate action or future product/process improvement.
Join featured presenter, Verna Manty Rodriguez, Founder and Principal of Manty Medtech and Adjunct Lecturer at Santa Clara University’s Bioengineering Department, to learn about:
- The importance of product risk management throughout the lifecycle of the medical device and how clinical trials contribute at all stages
- How medical device product usability and design can be better understood and improved through proper documentation, detail and tracking of adverse events
- The importance of timely and accurate reporting, trending and root cause analysis of adverse events, and the importance of updating adverse events in light of newly discovered information
- Why eClinical platforms should be evaluated for the potential to reduce entry errors and increase the quality of clinical trial data, thereby contributing to product risk reduction for patients
For more information or to register for this event, visit Reducing Medical Device Product Risk: The Key Role of Clinical Trial Data in Product Development.
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