How to Achieve 510(k) Application Success for Device Software: Avoid Pitfalls that Could Delay Your Market Entry
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Category FDA GXP Compliance - Medical Devices
Deadline: March 31, 2015 | Date: March 31, 2015
Venue/Country: Palo Alto, U.S.A
Updated: 2015-03-27 20:06:51 (GMT+9)
Call For Papers - CFP
Though the guidance regarding software in medical devices is not new, there remains some confusion in the industry. This training program will offer some clarity on the subject, and upon completing this session, attendees will understand the elements required for a 510(k) application when the device contains software.Why Should You Attend:The webinar will discuss the structure and level of detail required when a medical device is software or contains software. It will especially focus on the impact of the Level of Concern determination on the required documentation.Who Will Benefit:Regulatory managersProject managersRegulatory specialists who compose 510(k) applications for softwareProduct development managersInstructor Profile:Cheryl Wagoner has 20 years of experience in quality assurance, and regulatory affairs. She is currently the principal consultant/owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in quality, regulatory, clinical and compliance in the medical device and pharmaceutical industries.Note:Use coupon code 232082 and get 10% off on registration.For Registration:http://www.complianceonline.com/achieving-510k-application-success-for-device-software-webinar-training-703846-prdw?channel=ourglocal
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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