At no other point in history have everyday people experienced the rapidly increasing availability of having powerful technology in their hands than the time we are living in. Seemingly, new wearable or handheld technology launches every day to provide or analyze information about our state of health and how we live.
Through the use of these devices we have the hope of improving ourselves through better fitness, lifestyle modification and improved healthcare. The history of devices used in healthcare is fraught with examples of deadly failures. These failures led to the need and desire for regulatory oversight. Now these regulations – created to protect us – are struggling to keep pace with advancing technology.
How is a company to know whether they need to validate their device and how to meet regulatory requirements? In this webinar, we will provide you with practical considerations to support your success in the market.
William Hanlon, PhD,
Vice President, Head of Global Regulatory Affairs, Covance
Dr. Hanlon, Vice President and Head of Global Regulatory Affairs at Covance Drug Development, leads a group of 165 regulatory professionals advising clients on global, regional and local regulatory strategy associated with study design and regulatory agency interactions as well as drug development programs. The group provides a range of regulatory services for the creation and submission of regulatory documents in support of clinical trials, regulatory agency meetings and marketing applications.
Scott Thiel, MBA, MT (ASCP), RAC,
Associate Director, Navigant Consulting, Inc.
Scott Thiel, Associate Director at Navigant Consulting, Inc., has nearly 30 years of experience in the medical device, health information technology and in-vitro diagnostics industries. He assists clients with product development and commercialization, medical device software and connectivity (including consumer electronics interfaces), regulatory strategy and compliance, auditing, labeling and promotional material review, and quality system assessment, creation, and remediation.
- Understand why there is friction between consumer devices and traditional medical devices relative to development and marketing.
- Understand the nature and scope of changes related to regulation of mHealth devices.
- Understand the somewhat hidden costs to be managed in order to support a successful mHealth device.
- Product Management
- Research & Development
- Senior Management
- Compliance
- Regulation
