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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an On-demand
recording from June 2020.
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. This webcast will focus on
how to take a modern approach to the application of risk management throughout
the product lifecycle of a medical device.
According to the 2020 State of Medical Device Product
Development and Quality Management Report, nearly half (49%) of medical device
professionals say that they fully integrate risk management into their quality
management system (QMS) throughout the product lifecycle; while 22% do not
integrate risk management into their QMS, admitting risk documentation is a
substantial effort for their organization.
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 - rather than viewing this as merely a compliance activity.
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) followed by a question and answer session.
Intermediate: Content is designed based upon the
assumption that individuals have basic knowledge of the topic(s) and/or demonstrated
competence related to the topic(s). Higher-level concepts are introduced during
lectures; exercises requiring synthesis and/or application of concepts are
incorporated into the activity.
Upon conclusion of the program, you will understand:
Who Should Attend:
Jon Speer, Founder & VP of QA/RA at
Jon is a medical device industry veteran with over 20 years
of experience in a variety of roles including product development, project
management, quality and regulatory. He has helped dozens of devices get to
market over his career and is a thought leader, speaker, and regular
contributor to numerous leading industry publications.
Jon Speer is the founder and VP of QA/RA at Greenlight Guru,
the main contributing author of the publication and also the host of the #1
most downloaded podcast in the industry, The Global Medical Device Podcast.