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    FDA's Medical Device Software Regulation Strategy

    View: 173

    Website https://www.complianceonline.com/fda-medical-device-software-regulation-strategy-seminar-training-by | Edit Freely

    Category

    Deadline: February 03, 2020 | Date: February 13, 2020-February 14, 2020

    Venue/Country: San Diego, CA, U.S.A

    Updated: 2019-12-30 16:03:56 (GMT+9)

    Call For Papers - CFP

    medical device trade and healthcare professionals remain plagued by other issues, such as the interoperability of devices from different manufacturers, or software validation that is limited to the immediate use of the software rather than its performance with other software programs, and software hacking protection applications. In case of software malfunction, fixing the malfunction or bug can get more difficult as software gets increasingly sophisticated, customized by users and placed in a network system. Under these circumstances, it is difficult to decide who is responsible for managing and fixing software problems.

    This seminar will help those involved in overcoming these commercial and regulatory obstacles. It will highlight the need for firms to remain current with technological tools and strategy to remain competitive, and ideally, outside FDA’s regulatory radar. Going further, it will instruct participants on how to apply these tools and strategies to ensure the following factors:

    Software functionality

    Risk identification

    Software protection

    Problem detection

    Response strategy

    For those who have addressed these issues to meet FDA’s regulatory expectations, the course instructor, a former FDA official, will help identify a basic centering point to build a regulatory profile for your software products.


    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.