How to Integrate Risk Management throughout the Lifecycle of a Medical Device in the Coming Decade

By its very nature and application, there is an element of risk in the use of any medical device.

Understanding, balancing, and quantifying that risk enables a manufacturer to bring a product to market that provides significant benefit to patients and health care providers while minimizing the risks associated with the product.

With updated guidelines to risk management, outlined in ISO 14971:2019, the industry is still waking up to the benefits of integrating design, risk, and postmarket quality activities over the course of the device lifecycle.

This webcast will review the application of a modern approach to risk management (risk analysis, risk evaluation, risk control, overall residual risk evaluation, production and postproduction monitoring) as a product moves through the product lifecycle (concept, development, launch, postmarket, obsolescence).

Specifically This Webinar Will Cover: 

• How risk management is an integral part of all phases of the product lifecycle
• Common challenges and data-driven insights on key markers for risk management
• How to leverage proven strategies, tactics, and technologies to control and monitor risk management activities
• How to achieve closed-loop traceability via a risk-based approach to postmarket surveillance to monitor and address product issues and ensure patient and healthcare provider safety.
• Ongoing risk management to balance patient/health care provider risks versus benefits of the medical device.
• Q&A session

Who should attend?

• Medical Device Executives

• Regulatory Affairs Professionals and Management

• Quality Professionals and Management

• Clinical Affairs Professionals and Management 

• Product Development & R&D Engineers and Management

About the presenter:

Jon Speer is the founder and VP of QA/RA at Greenlight Guru and the main contributing author of this publication. Jon is a medical device industry veteran with over 20 years experience having helped dozens of devices get to market over his career in a variety of roles including product development, project management, quality and regulatory. He is a thought leader, speaker and regular contributor at numerous leading industry publications. He is also the host of the #1 most downloaded podcast in the industry, The Global Medical Device Podcast.

About greenlight guru

Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our homepage to learn more.