Introductory 1 day Human Factors Assessment

SoftwareCPR® – Human Factors and Usability Engineering Assessment Does the design of your device promote safe and effective use? Are you ready for an FDA regulatory submission requiring HFE/UE report? Do you maintain a usability engineering file for your products? Is it complete? Do you have a systematic process for identifying and analyzing use error? Is the identification of use error integrated into your overall device Risk Management Plan? Would your usability engineering process satisfy both FDA inspection and NB audit? If you answered No to any of those questions, you may be interested in a “ONE DAY”! You may have thought before, “One day we will get our usability engineering process in order. Well, that day is now! So what is a “ONE DAY”? In just ONE DAY onsite with your team, SoftwareCPR® will: Work with your team to briefly assess your usability engineering file and review your UE process for compliance to FDA and international standards. For current projects, we will evaluate the adequacy of the human factors testing completed to date and determine, what, if any testing may still be necessary. Our clients range from large corporations to small start-ups. Many start-up companies find that having us provide hands-on support of all of their human factors activities helps speed up product submissions and alleviates the need for hiring extra staff. Use a risk-based approach. From the perspective of the FDA and the new IEC 62366-1, formative and summative evaluations performed to demonstrate safety and effectiveness of device use are dependent upon a comprehensive analysis of the use-related hazards. Have you identified which use errors could result and have you effectively mitigated those errors? Our staff can assist you with answering these questions and completing the entire risk analysis process. Leverage our expertise and extensive experience with software verification and validation! By coordinating and strategically planning software development milestones with usability evaluation goals, the overall development program can be highly optimized. We often help our clients plan and manage the software development and V & V process to optimize opportunities for UE evaluations. We can advise on multiple levels of prototypes to support the process. Our staff has many years of experience managing, developing and testing regulated devices. We recognize that usability engineering must be integrated with the overall development program considering FDA expectations, overall device risk, and other factors. We have experience with legacy devices and UOUP! For a limited time, SoftwareCPR® is offering a discounted “ONE DAY” onsite assessment of your Human Factors / Usability engineering process and project artifacts for a selected project, and then cap off the day with a short training session on 62366 and FDA expectations for human factors engineering and usability engineering! Cost $1495.00 excluding travel expenses. For more information, call or email Brian Pate at 813-766-0563 We only have a limited number, so be the first to get your ONE DAY scheduled!

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:  June 5-7, 2024
Boston, MA

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

Registration Link:

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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: Tuesday, January 23 through Friday, January 26 from at 11 am – 3 pm EST

Virtual via Zoom

Registration Link:

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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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