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    How to Achieve 510(k) Application Success for Device Software: Avoid Pitfalls that Could Delay Your Market Entry

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    Website http://bit.ly/1Nhj4BB | Want to Edit it Edit Freely

    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 managers

    Project managers

    Regulatory specialists who compose 510(k) applications for software

    Product development managers

    Instructor 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.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.