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FDA's Medical Device Software Regulation Strategy

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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.
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