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:
Medical Device Executives
Regulatory Affairs Professionals and Management
Quality Professionals and Management
Clinical Affairs Professionals and Management
Product Development & R&D Engineers and Management
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.
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.