Healthcare Medical Software/Applications - Risks, Validation & Interoperability

Day 1 / morning (Presenter: Casper E. Uldriks)

• Risk based classification
• Proposed regulation and guidance
• Public comment
• Public meetings for FDA
• Private meetings with FDA
• Future regulatory strategy

• Premarket requirements
• Post market requirements
• Marketing boundaries
• Regulatory action
• Enforcement action

Day 1 / afternoon (Presenter: Martin Browning, guest speaker)

• Design and validation
• Corrective and preventive actions
• FDA inspections

• Recall risk determination
• Recall strategy
• Required FDA reporting

(Case studies)

Day 2 / morning (Presenter: Casper E. Uldriks)

• Regulatory scope
• Device classification criteria
• Implementation
• FDA
• Industry

Day 2 / afternoon

• Device interface
• Failure plan
• Servicing
• Professional and consumer use

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, senior manager in the Office of Compliance and as an Associate Center Director in the Center for Devices and Radiological Health. He developed enforcement actions, participated in the implementation of new statutory requirements, managed device regulatory programs and was recognized as the agency’s expert in a number of statutory provisions and regulations. Starting in 1995, he trained the FDA’s investigators on the FDA’s legal authority and CDRH’s regulatory requirements and procedures. He continues to teach the FDA’s employees to this day. He is recognized and sought out as an exceptional and energetic speaker. Many of his engagements focus on advertising and promotion, recalls, corrections and removals and enforcement. His comments are candid and of practical value. He understands how the FDA thinks, operates and where it is headed.

Cap also served in the FDA’s Office of Legislative Affairs for 5 years as the FDA’s congressional liaison for its medical device program. As a federal “Legislative Fellow” he worked for one year in a congressional subcommittee for the Energy and Commerce Committee where he drafted proposed FDA legislation for the regulation of human tissue. He managed and wrote testimony for the Commissioner for several congressional oversight hearings concerning FDA’s device program.

Cap now works almost exclusively on medical device issues at Olsson, Frank, and Weeda (OFW Law) in Washington, D.C. He counsels clients on wide range of topics, including: FDA inspections; import operations; advertising and promotion; corrective and preventive actions; medical device reporting and corporate reorganization to improve conformance to the FDA’s requirements.

Martin Browning He has more than 30 years of hands-on experience at the FDA and as a highly sought-after advisor to industry. His 22-year career at FDA included work in the field offices as an investigator and in FDA headquarters as a senior manager in the Office of Regulatory Affairs (ORA). He capped his FDA career by serving as a special assistant to the Associate Commissioner for Regulatory Affairs.

Martin also served as vice chair of FDA’s electronic record and signature working group, where he helped draft the original 21 CFR Part 11 regulations. In addition, he served as the chair of the U.S. government’s ISO 9000 committee and was a member of the FDA committee that developed the medical device Quality System Regulation (QSR).