2-Day In-Person Seminar by Ex-FDA Official

FDA's Medical Device Software Regulation Strategy

BY: Casper (Cap) Uldriks,

Former Associate Center Director of FDA's CDRH

November 19-20, 2020
Boston, MA
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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.

  • How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump?
  • Can one software program defeat the performance capability or back up safety features of another software program?
  • When interoperability surface, which software manufacturer takes the lead to solve the problem and deal with proprietary software issues?

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:

  • 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.

Learning Objectives:
  • Understanding FDA legal authority
  • Applying FDA classifications / risk controls
  • Understanding FDA and NIST software guidance
  • Identifying the quality system regulation for risk management, software verification and validation
  • Identifying cybersecurity issues and developing a planned response
  • Identifying and resolving interoperability issues
  • Figuring out the scope of FDA’s mobile apps regulation
  • Learning about bug updates classified as recalls by FDA
  • Future device software applications
Who will Benefit:
  • Regulatory Affairs Managers
  • Quality Assurance Managers
  • Software Design Engineers
  • Manufacturing Managers
  • Compliance Department Personnel
  • Hospital Risk Department Personnel
  • Software Program Marketers
  • IT Security Managers
  • Marketing Personnel
Day 01(8:30 AM - 4:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  • FDA Authority and Regulatory Program
    • Types of Software Devices
    • Regulatory Strategy
    • Risk Classification
      • Function and outcome
    • Medical Device Data Systems (MDDS)
    • Office of the National Coordinator (ONC) for Health Information Protection
    • Software Regulatory Applications
    • FDA Guidance
      • Premarket submissions
      • Paradigms: aeronautics
    • Quality System Regulation (QSR)
      • Design verification and validation
      • Voluntary standards
      • Corrective and prevent action plans
    • Voluntary Standards
    • Recalls:
      • Service / maintenance / recall
      • Implementation strategy
    • Corrections and Removals Reporting
    • Updates: FDA vs. Non-FDA
    • Predictive Analytics
  • Interoperability
    • Compatibility by Design
      • Hardware
      • Software
    • Labeling
      • Precautions
      • Instructions for use
    • Use of Voluntary Standards
    • Proprietary Information
    • Failure Management / Follow Up
    • User’s vs. Manufacturer’s Legal Responsibility
      • System configuration
      • Customization
      • Environment of use
        • Professional
        • Home use
Day 02(8:30 AM - 4:30 PM)
  • Cybersecurity
    • Device Vulnerabilities: Malfunction and Failure
    • Pre-Emption Design
    • Latent Malware/Virus
    • Post-Event Management
      • Corrective action for software
      • Disclosure to users
    • National Institute of Science and Technology Report
  • Medical Mobile Applications (Mobile Apps)
    • Mobile Apps Defined as a Device
    • FDA Regulatory Strategy
    • FDA Guidance
    • National Institute of Science and Technology Report and Collaboration
    • Updates (FDA vs. Non-FDA Updates)
      • Criteria for corrective and preventive action deemed recalls
      • Reports of corrections and removals
      • Reports of adverse events
    • Professional vs. Lay Use / Home Use
    • Labeling: Instructions for Use and Precautions
    • Environment of Use
    • FDA Regulation of Accessories
    • Federal Communications Commission (FCC) Regulation
Casper (Cap) Uldriks
Casper (Cap) Uldriks Former Associate Center Director of FDA's CDRH

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.

Register Now

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$1,499.00

Seminar One Registration

November 19-20, 2020, Boston, MA
(Registrations till June 20, 2020 - $1499)
(Registrations after June 20, 2020 - $1699)


The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both the days.
For discounts on multiple registrations, contact customer care at +1-888-771-6965.

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Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ customercare@fdatrainingalert.com

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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future FDATrainingAlert event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event FDATrainingAlert cancels the seminar, FDATrainingAlert is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

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