Course Descriptions

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 IEC 62304/FDA Software Process, Quality System Software (CSV, QS, Manf/process, Engineering Tools), 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 & UL 5500, IEC 80001, AAMI TIR45, and IEC 80002 and can train your staff in pragmatic and efficient methods of conformance to standards.

Our training can be 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.

IEC 62304 and Emerging Standards Impacting Medical Device, Medical Mobile App, and HealthIT Software
Quality System Software Validation
Being Agile and Compliant
Health Data Cybersecurity, Confidentiality and Security Training
Software Risk Management
Other Training Courses
Our 3-day 62304 and emerging standards training course is offered publicly each year and provided onsite many times throughout the year.  Our public course is very popular, drawing students from Asia, Canada, Europe, the Near East as well as the US each year.  One reason for the popularity is not only our expert knowledge of the regulations and standards, but detailed example and insight of how to apply them in an agile and efficient manner.  Our course focuses on ensuring the participants understand the standards and US regulations that drive the processes for creating medical device software and the activities and documentation expected by regulators and auditors.  Beyond the regulations and standards, our approach is to educate on the intent and current expectations so that the participants are able to make informed decisions in the future.  Our training covers regulatory, quality, and the details of the software development process.  Our software risk management module utilizes IEC 80002-1 concepts and explains the very difficult process of how to perform risk analysis on software.
We can tailor our exercises and examples to SaMD, algorithm heavy software, embedded software, microcontrollers, and others.




The FDA General Principles of Software Validation guidance states “Any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use, as required by 21 CFR 820.70(i). This requirement applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system.

Our Quality System Software Validation (QSS) course focuses on software that requires validation activities and documentation that is not contained or operated in the medical device.  This includes topics such as:

Quality System Process Automation and Records Management software

ERP, Complaint Handling, CAPA systems, Computer System Validation, etc.

Manufacturing and/or production Process Automation software

Manufacturing and/or production Quality Control software

Measurement systems, Calibration, spreadsheets, etc.

Engineering and Validation tools software

Our 3-day QSS course is typically offered publicly every year and can be provided onsite many times throughout the year.  We use our expert knowledge of the regulations and standards, to provide detailed examples and insight of smartly applying methods and strategies to ensure quality and minimize inspection risks.  We cover the use of process mapping and critical control points analysis to develop efficient methods of QSS validation.


This course helps the student understand how Medical Device, Medical Mobile App, and HealthIT Software can be developed using agile methods and meet the FDA expectations for medical device software and be compliant with IEC 62304.  The course is framed around IEC 62304 and how the standard can be used to ensure agile methods and approaches to software development will include the proper activities and deliverables for safe and effective software. The course uses concepts from AAMI TIR45 to help communicate how agile methods can, when used properly, improve software quality. The course also references US regulations and FDA guidance to address potential gaps that can occur with agile methods when one doesn’t consider the all important user need of “safety”.
This course can be tailored to SaMD, small embedded systems, or large and complex systems.  This 3-day course integrates exercises and workshops.

This 2-day course has two parts:  Day 1 is an overview of basic information security related to PHI and PPI using ISO ISO 27799:2016 Health informatics and AAMI TIR57, including expectations for pre-market submissions.  Day 2 focuses on client specific workflows, vulnerability analysis, and cyber and physical risk controls.  Day 2 can be setup as more of a workshop for organizations lacking detailed policy and procedures in this area.

This 3-day software risk management course is a very intensive and immersive into the application of IEC 80002-1.  The course is highly exercise and workshop oriented and can be tailored to client products or sub-systems.  Students will come away fully confident in how to perform software risk analysis and understand the concepts of ISO 14971, IEC 8002-1, and the software risk management requirements of IEC 62304 AMD1:2015.

Ask how these courses can be customized for your products and processes:

  • Human Factors and Usability Evaluation Design
  • Quality System Regulation
  • Design Control
  • FDA Software Submissions
  • Computer System and Design Tool Validation
  • 21 CFR Part 11
  • Articulating your approach to FDA
  • Software CAPA
  • Production Software Issues and Approaches
  • Computer System Validation Auditing
  • Software Technical Reviews
  • Software Testing

SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  TBD

Email to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:




Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

Registration Link:

Register Now



Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

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