The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: July 23, 2013 from 10am to 11:15am
Location: Online Event
Street: 2600 E. Bayshore Road
City/Town: Palo Alto
Website or Map: http://www.complianceonline.c…
Phone: +1-650-620-3915
Event Type: medical, device, webinar
Organized By: Referral
Latest Activity: Jul 15, 2013
This integrated risk management training for medical devices will discuss how to incorporate risk management as per ISO 14971 guidelines in all phases of medical device development. It will highlight the documentation needed to support the decisions made as part of the risk management process.
Why Should You Attend:
ISO 14971 Medical devices - Application of risk management to medical devices is a voluntary standard that medical device manufacturers must incorporate into their design and development process in order to ensure medical devices designed are safe and effective. The FDA now also recognizes ISO14971, and can audit to it if manufacturer's claim they conform to it. Although ISO 14971 has been in place since 1998, many companies still find it difficult to properly interpret the requirements of the standards and having a risk management process which is not helpful in designing robust, safe medical devices.
This webinar will cover all major elements of ISO 14971 and present a methodology for integrating the requirements of this standard into the product development process to ensure that the requirements of the standard are met, and the medical device is designed to be safe and effective. The webinar will specify how risk management activities are incorporated in all phases of development, and what supporting documentation needs to be gathered in order to ensure that decisions made based on what is learned as part of the risk management process are adequately justified and documented.
Areas Covered in the Seminar:
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