Healthcare Medical Software/Applications - Risks, Validation & Interoperability
Casper E. Uldriks,
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The complexity and expanding use of software outpaces what FDA and industry understand in a regulatory context. This leaves you and FDA at a loss for developing a practical regulatory program, especially one that can accommodate future designs and use. FDA’s publication of the final rule for the regulation of Medical Device Data Systems (MDDS) lays out criteria for the lowest level of software regulation. Future criteria remain fluid based on changing technology and its likely evolution. In the meantime, device firms need to establish a regulatory approach that can be adapted to future regulatory paradigms and FDA initiatives.
Software based medical device firms need to stay ahead of FDA’s regulatory approach, not catch up. You will learn how to enter and survive the world of the FDA’s regulatory reach. You will participate in an interactive learning experience with experts in FDA’s existing approach to software regulation and what you can see on the horizon. Attendees will learn how to understand their direct or indirect software based products in terms of current FDA requirements and policy. Armed with this information, a firm can develop an informed regulatory strategy.
- Understand FDA’s regulatory approach.
- Identify software regulation criteria.
- See the impact of software regulation.
- Learn to manage software’s risk to health.
- Learn Quality Systems manufacturing requirements.
- Understand FDA’s initiative for regulating mobile applications.
Your course instructors are Mr. Casper (Cap) Uldriks and Mr. Martin Browning who brings over 62 years of combined experience working in the FDA.
Mr. Casper 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(CDRH) . 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. He continues to teach the FDA's employees to this day.
Mr . Browning has more than 30 years of hands-on experience at the FDA working in the field offices as an investigator and in FDA headquarters as a senior manager in the Office of Regulatory Affairs (ORA). He 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.
Who Should Attend:
The scope of FDA’s regulation extends, for example, to the following types of commercial and clinical activity. Manufacturers of medical devices that rely on software; vendors of off-the-shelf software; vendors of proprietary stand-alone medical device software and clinical facilities that develop their own medical device software or purchase a software platform that they customize. This has become a significant issue for FDA that can potentially reach all institutional health care facilities. A new regulatory issue involves mobile application software designers, managers and marketers who face FDA regulation and are vulnerable to FDA enforcement action now. All of these types of firms need to understand how the FDA does and will regulate them in the future. Software users must also account for the interoperability of their software systems.
Anyone in the medical device field is affected by FDA regulation, all the way from medical device data systems (MDDS) to software that makes clinical decisions and treatment orders that are automatically implemented. This last issue was a major motivating factor in the FDA’s aggressive development its regulatory program for standalone software or software based medical devices. For all medical device software design engineers and users, there is an additional problem of cyber-security, which will likely be moved to the forefront of risk management.
Medical device software is a highly interdependent by the features of technology, safety and effectiveness. The FDA requirements cover medical device software from the design phase, final use and correction of software programs. This means several job functions directly relate to making and marketing medical device software or software based medical devices.
- Medical Device Software Design Engineers
- Senior Managers of Manufacturing Operations
- Regulatory Affairs Auditors
- Managers for software based medical devices
- Risk Managers
- Sales and Marketing
- Software Vendors
- Institutional and Clinical Software Users
- Cyber Security Manager
Day 1 / morning (Presenter: Casper E. Uldriks)
FDA’s regulatory approach
Impact of regulation
- 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)
Quality Systems regulation
- Design and validation
- Corrective and preventive actions
- FDA inspections
- Recall risk determination
- Recall strategy
- Required FDA reporting
Day 2 / morning (Presenter: Casper E. Uldriks)
Medical Device Data Systems (MDDS)
- Regulatory scope
- Device classification criteria
Day 2 / afternoon
- Device interface
- Failure plan
- Professional and consumer use
Meet Your Instructors
||Casper (Cap) Uldriks
An ex- FDA expert and former Associate Center Director of CDRH
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.
An Ex-FDA veteran served as vice chair of Electronic and Signature working group
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).
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