FDA's Medical Device Software Regulation Strategy
Former Associate Center Director of FDA's CDRH
Former Associate Center Director of FDA's CDRH
The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated.
This seminar will focus on addressing these concerns and educating participants on FDA’s recent medical device software regulation strategies.
The 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:
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.
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.
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