2019 Edition of 62304 Training

What does one need to know about IEC 62304?

In our 3-day 62304 Training course, we flow through the software development lifecycle drawing attention to requirements of the standard as well as related standards and always current FDA expectations from our experience.  The topics we plan to cover in our 2019 course are below.


  • Regulatory Background – US FDA, EU MDR
  • Types of Software – Medical Device, Health-IT, General Wellness, Cloud Services, Mobile Medical Apps, Personal Health Software
  • Design Controls / 62304 / 82304 in the context of a system
  • Overview of related standards and guidance 60601-PEMS, 82304 Health Software, 80002-1 Risk Management Background and Structure, Cybersecurity 80001-1 IT Networks, 62366 Usability, Privacy HIPAA and EU
  • Use of Standards
  • 62304 Software Safety Classifications / Contrast with FDA LOC
  • Software Development Process Planning / Agile Methods Planning
  • SOUP (open source, commercial), Legacy Software
  • “Real” Design Input / Requirements / Formative usability
  • Architecture and Detailed Design
  • Implementation, coding, unit verification
  • Integration and integration testing
  • Software Risk Management
  • Probability and Severity related to software
  • Harms, Hazards, Identifying Causes and Risk Controls
  • Process as Risk Control
  • Managing Risk after release
  • Document Hierarchies and Traceability / Electronic records / Data Models
  • Maintenance Process / Problem Issue and Defect Management
  • Validation / 82304 / Summative usability
  • Release, Configuration Management / Rapid release
  • Networked Devices / Cybersecurity / 80001-x
  • SaMD / Design Review

One reason for the popularity of our course is our background and experience with many, many examples of approaches no matter your SDLC, type of software, or organizational structure.  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.  Learn more at our 62304 Training page.

About the author

Brian is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

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 training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

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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: March 7 & 28, 2024

Virtual via Zoom

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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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