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.

 

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.

Questions

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