62304 Training

62304 Training Course Overview

Our flagship three-day 62304 training course provides a clear understanding of the 62304 standard for medical device software and much more.  With this training, participants will compare and contrast 62304 with FDA expectations.  Ample time is provided for discussing approaches for alignment between 62304 and FDA expectations.  Additionally, participants will learn of other standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).  Latest updates includes FDA Pre-Cert program, mobile apps, and machine learning / artificial intelligence (AI)


Participants will gain practical advice and pragmatic experience with all types of medical software.  The course goal is to provide a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

62304 Training Key topics

  • Training includes Amendment 1 changes to 62304 (changes to risk and dealing with legacy software)
  • Using Agile methods for medical device and HealthIT software – while remaining compliant!
  • 62304 training that integrates Software Risk Management guidance from 80002-1
  • Training with 62304 Software Safety Classifications to prioritize rigor and documentation
  • IEC 82304 for Health IT and standalone software and how 62304 training complements
  • Cybersecurity planning, evaluation, and validation
  • IEC 62366-1 formative and summative usability/human factors for validation

Plus this bonus material

  • Update on emerging standards impacting medical device and HealthIT software
  • Discussion on how privacy requirements (e.g., HIPAA) might intersect with risk management activities and cybersecurity procedures
  • Training with 62304 relevant medical standards for networking safety
  • Workshops and exercises integrated throughout teaching modules
  • Many opportunities for networking with other medical device and HealthIT colleagues


  • Understanding and applying software risk management expectations from 62304
  • Discovering the essence of design input
  • “Flowing down” design input to 62304 level requirements
  • Software verification planning


62304 public training course often includes John F. Murray, Jr. as faculty.  John is a 25 year FDA veteran that served as a regulatory and compliance expert for FDA regulated computers and software.  His expertise includes FDA software related guidances, software device classification determination, pre-market software review, post market software inspectional 483’s, additional information software requests, Digital Health Pre-certification, AAMI Software related TIRs and related medical device software standards.

Partner and General Manager, Brian Pate, a frequent course instructor, has also taught the AAMI/FDA course on Software Regulation to FDA Reviewers at FDA, and Brian is currently the lead faculty for the public version of that course taught annually along with FDA staff.  He served on the TIR working group that created the AAMI TIR45-2012 Technical Information Report Guidance on the use of Agile practices in the development of medical device software and is participating with the revision of the 2nd edition of TIR45. He has also served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course.  In March 2015, Brian also served as an instructor for the AAMI Design Controls course in Baltimore.  Brian is also a member of the Underwriters’ Laboratories Standards Technical Panel 5500, Remote Software Updates.

Other faculty that are involved in course updates and occasional teaching

Alan Kusinitz, our founding partner, has provided training (including 62304 training) internally for FDA and Health Canada, and is the developer of the AAMI/FDA course on Software Regulation, which he taught for many years with FDA’s internal experts. He has also taught the AAMI courses on the Quality System Regulation as well as Safety Assurance Cases.

Sherman Eagles, was the convener of IEC/ISO joint working group that developed IEC 62304 Medical device software life cycle processes.  He also was the convener of IEC/ISO joint working group that developed IEC 80002-1 Guidance on the application of ISO 14971 to software.  Additionally, Sherman was the convener for the working group that added the software requirements to the 3rd edition of 60601. He was also a member of the working group that inserted risk management throughout the 3rd edition. As a convener, he was a member of the chairman’s advisory group that oversaw the development of the 3rd edition. As such, Sherman has been part of training that the 3rd edition team did in Paris, Frankfurt and Washington.

Partners Lucille Ferus, Alan (Alan was co-chair), Sherman, and Brian also served on the TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1).

SoftwareCPR offers other training courses – see our High Impact Services!