Reducing Medical Device Product Risk: The Key Role of Clinical Trial Data in Product Development, Upcoming Webinar Hosted by Xtalks

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This webinar will discuss the importance of thorough, accurate and timely reporting of adverse events from feasibility studies through post-market clinical trials, as well as how medical device development teams can follow best practices in using the information in product risk management

Xtalks Life Science Webinars

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.

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.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

Contact:
Candice Tang
Tel: +1 (416) 977-6555 ext 400
Email: ctang@xtalks.com

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Candice Tang
Xtalks
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