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Sponsored Webcast: How to Integrate Risk Management Throughout the Lifecycle of a Medical Device in the Coming Decade

1.0
RAC Credits
Thursday, 25 June 2020 (12:00 PM) - Thursday, 25 June 2020 (1:00 PM) Eastern Time (US & Canada)


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.

 

Learning Level:

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.

 

Learning Objectives:

Upon conclusion of the program, you will understand:

  • 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.

 

Who Should Attend:

  • Medical device industry executives

  • Quality professionals

  • Regulatory professionals

  • Clinical affairs professionals

  • R&D engineers

 

Speaker:


·         Jon Speer, Founder & VP of QA/RA at Greenlight Guru

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.

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