SoftwareCPR® Training Services
Next SoftwareCPR® Training Course (Contact for info) Dates Location Instructors
IEC 62304 and Emerging Medical Device and HealthIT Standards January 24-26, 2018 Sunnyvale, CA Brian Pate
Alan Kusinitz

Online Registration Link - Click Here

Click HERE for SoftwareCPR® group rates at the Domain Hotel in Sunnyvale.

Regulatory Requirements for Software Validation in the Medical Industry Mar 19 - 21, 2018 Arlington, VA USA Brian Pate
John Murray, FDA (tentative)
Effective Application of Agile Practices in the Development of Medical Device Software Oct 15 - 16, 2018 Las Vegas, NV USA Brian Pate

Instructors for internal FDA software validation training and lead instructors for public AAMI/FDA Software Regulation Training courses, Alan Kusinitz, SoftwareCPR®’s Founder, and Brian Pate develop and coordinate SoftwareCPR® training courses on the Quality System Regulation, Design Control, Software Regulation and international medical device, Usability, and HealthIT Standards.

Our instructors understand regulatory agency expectations and can train your staff accordingly and coach them on how best to articulate and defend your approaches in FDA terms.

Our instructors have been in involved in software standards development including IEC 62304, AAMI SW68, AAMI TIR32, IEC 60601-1 PEMS, UL 1998, IEC 80001, AAMI TIR45, and IEC 80002 and can train your staff in pragmatic and efficient methods of conformance to standards.

Our training is tailored to your needs, your products, your regulatory perspective, and your business objectives.

Our training includes FDA enforcement examples, key FDA guidance, electronic, checklists, and other educational aides.

We offer both awareness and skills training. Awareness training courses provide short overviews of key concepts and requirements ranging from 2 hour executive overviews to one day introductory courses. Skills training courses are generally multi-day and are highly interactive using short exercises, formal workshops, and free form and structured instructional Q&A.

Fully customized courses integrating customer policies and procedures are prepared on request and can be integrated into internal company training programs or produced as self-study computer-based training modules.

Tailored Training Courses (Contact us for how these courses can be customized for your products and processes)

  • FDA Software Regulation & Validation
  • IEC 62304, TIR32, 60601-1 PEMs
  • Being "Agile &" Compliant
  • Human Factors and Usability Evaluation Design
  • Medical Device Risk Management
  • Software Risk Management
  • Medical Device Software Cybersecurity
  • Quality System Regulation
  • Design Control
  • FDA Software Submissions
  • Computer System Validation
  • Design Tool Validation
  • 21 CFR Part 11
  • Software Lifecycles
  • Policies and procedures
  • Articulating your approach to FDA
  • Software CAPA
  • Production Software Issues and Approaches
  • Computer System Validation Auditing
  • Software Technical Reviews
  • Software Testing
  • For more information contact us at or by phone at 781-721-2921