Mr. Casper Uldriks

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Profile

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.  Professional credentials: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.

3 results Found
Recorded Webinar

FDA Regulation of Software Cybersecurity and CAPA

Cybersecurity has become a critical risk for the medical device industry. The FBI has warned the device industry and the FDA that it is not prepared for managing this problem. FDA lacks the expertise to add any insightful or technical guidance on ...

  • Basic & Intermediate & Advanced
  • 60 Mins
Seminar

FDA’s Unprecedented Changes in Software Regulation

Software’s level of complexity and use keeps expanding at exponential levels. Likewise, the potential risks to health and loss of privacy follow suit. Ransomeware attacks hold software programs hostage until you pay the culprit thousands of ...

  • Basic & Intermediate
  • 2 Mins
  • Dec 13, 2018