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 Pate helps medical device companies achieve efficient and FDA regulatory compliant product development to produce higher quality and clinically valued software. He began his career in clinical research in 1985 with the Department of Anesthesiology at UAB developing closed-loop control systems for the automated delivery of gases and control. In 1990, he made the switch from university research to the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time embedded systems and clinical information systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical. Today, he is a Partner and the General Manager of Crisis Prevention and Recovery LLC (dba SoftwareCPR®), a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software. He has taught the AAMI/FDA course on Software Regulation to FDA Reviewers at FDA and is currently the lead faculty for the public version of that course taught annually along with FDA staff. Brian served on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1). He later served on the original AAMI/FDA working group that created the AAMI TIR45-2012 TIR Guidance on the use of Agile practices in the development of medical device software and is currently the co-chair leading the creation of the 2nd edition of TIR45. He has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course. Brian also served as an instructor for the AAMI Design Controls course. He is also a member of the Underwriters’ Laboratories Standards Technical Panel 5500, Remote Software Updates. He now serves as a member of the AAMI Software Committee.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.


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