Emerging Standards Impacting Medical Device Software and Health IT

01/31/2017 - 02/02/2017
8:00 am - 5:00 pm



IEC 62304 and Emerging Standards Impacting Medical Device Software and Health IT


Center for Advanced Medical Learning and Simulation (CAMLS), Tampa, Florida
124 S. Franklin, Tampa, Florida 33602


January 31 – February 2
8:00 a.m. to 5:00 p.m.



SoftwareCPR® is offering its fourth public course entitled “IEC 62304 and emerging standards impacting Medical Device software and Health IT”. The course is based on the international medical device software standard ANSI/AAMI/IEC 62304 and will address recent amendments, 2nd edition, related standards, and how these standards intersect FDA guidance and US regulations.
This course will include teaching modules, interactive exercises, workshops, and ample time for discussion and networking during breaks and meals.



This course is designed for Quality Assurance and Regulatory Affairs professionals, Product Owners, Scrum Masters/Coaches, Software Development Managers/Engineers, Risk Management, and Test Engineers.


Upon completion of this course, learners will be able to:


  • Understand the requirements of 62304 and how they relate to FDA expectation for medical device software.
  • Understand recent and upcoming changes to 62304 (e.g., Amendment 1, 2nd Edition).
  • Understand the forthcoming for Health IT and standalone software standard 82304.
  • Understand how human factors and usability engineering apply to medical device and HealthIT software development, and integrating 62366 requirements into your software development process.
  • Understand the software risk management process using the international report IEC 80002-1.
  • Understand how cybersecurity requirements impact the software development lifecycle. Overall learning objectives apply to all professions in the target audience.



  • ANSI/AAMI/IEC 62304:2006, AMD1:2015
  • Emerging standards affecting software: IEC 62366-1, 82304, 80002-1
  • Alignment and comparison of 62304 with FDA expectations.


A preliminary agenda is available at the end of this document.


Registration Fee: $1,920.00 before October 15, 2016; $2,395.00 after October 15; Government rate of $800.00.  Other discounts for multiple students from one company.


To register, click here.

The registration fee for this course includes course materials (PDF), continental breakfast and lunch for each day of the course, and a SoftwareCPR® certificate following course completion.


Cancellations prior to September 15, 2016 are eligible for a full refund.  Cancellations prior to October 15, 2016 are eligible for a 50% refund.  Cancellations after October 15, 2016 are not eligible for refund, but substitutions are encouraged. All eligible refunds are less any credit card fees.


The course does not require medical device regulation or international standards knowledge.  The learner should have at least a conceptual understanding of the product development process, and ideally the software development process.


To achieve course completion, learners are required to:

  • Pay the registration fee
  • Attend all training sessions
  • Participate in workshops and training exercises


Hotel rooms at a discount rate are available within walking distance to The Center for Advanced Medical Learning and Simulation (CAMLS).

Hilton Tampa Downtown:  A room block is has been secured at a special rate of $209/night and can be booked via the CAMLS link: Tampa Hilton Downtown Link

Nearby downtown hotels can also be viewed here.


SoftwareCPR® certificate of completion.  Instructors:  Alan Kusinitz – Founding Partner at SoftwareCPR® and Brian Pate – Partner at SoftwareCPR®.

Alan has provided 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.  Alan and Brian recently taught the AAMI/FDA course on Software Regulation to FDA Reviewers in July 2014 and a public course in May 2015.  Brian was the lead faculty for the Software Regulation course in March 2016 in Baltimore, and will lead again in April 2017.

Brian 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.  This group was privileged to have FDA staff participate with the group providing FDA input to the TIR on these practices.  Brian has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course, and will be teaching the class again in 2016.  Brian also served as an instructor for the AAMI Design Controls course in Baltimore in March 2015.

SoftwareCPR® partner, Sherman Eagles, was the convener of IEC/ISO joint working group that developed IEC 62304 Medical device software life cycle processes and 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.

SoftwareCPR® Website:  www.softwarecpr.com


SoftwareCPR® provides full service regulatory compliance and premarket submissions support for Medical Device Manufacturers including quality systems development, risk management – including for Health IT and Standalone Software, Human Factors and usability engineering, as well as hands-on validation services for Pharmaceutical and Medical Device companies. SoftwareCPR® also has extensive experience related to FDA enforcement action representation and negotiation and have served as expert witnesses.


Travel, lodging, and meals (other than stated above) are not provided by the course and is the responsibility of each attendee.

The opinions and recommendations provided by SoftwareCPR® during the course are based on the instructors knowledge of FDA regulations, guidance documents, historical FDA enforcement information, presentations, experience from training it has provided directly to FDA and Health Canada, and standards together with their experience and training in providing suggestions to many medical device manufacturers and HealthIT companies.  Many aspects of FDA regulation are interpretational and exact FDA action can be unpredictable.  SoftwareCPR® is not a law firm and does not provide legal advice.


If you have questions or would like further information, please contact Brian Pate at 813.766.0563 or brian@SoftwareCPR.com.


Start Time Event Topic



Day 1 Day 2 Day 3
7:30 AM Continental Breakfast (provided) Visual,

Interactive, Breakouts

8:00 AM Morning Session (breaks provided)
Regulatory Background, Standards, Types of Software Implementation and Testing Documentation
12:00 PM Lunch (provided)
1:00 PM Afternoon Session (breaks provided)
Planning, Requirements, Architecture & Design Risk Management Mobile Apps, Cloud, Cybersecurity
5:00 PM End of Daily Course Instruction Course Conclusion