Medical Device Software Testing- 

Advanced Level


Classes offered in San Ramon, CA and onsite at your facility

NOW OFFERING WEEKEND COURSES! We are here to accommodate your busy schedule at work. Get certification training and advance your career with low or no impact to your work week.

Upcoming Classes



This is an Instructor-led course focused on preparing you to apply your ISTQB Foundation Level in Software Testing knowledge to a FDA regulated industry. 

The two-day Medical Device extension course is critical for all software testers working in the Medical Device and Healthcare industries. Learn the crucial elements of IEC 62304, ISO 14971, 21 CFR § 820.30, FDA General Principles of Software Validation, IEC 62366-1, and other applicable international and regulatory standards as they apply to  software testing activities and deliverables.

Free for use templates for

  • Software Test Plans
  • Software Test Procedures
  • Software Test Report
  • Software Trace Matrices
  • Software Defect Evaluation Report
  • Software Regression Plan
  • Software Tool Validation Plan
  • and more



Course Tuition Includes

  • Instructor-led two-day course
  • Course notebook with all slides
  • Electronic version of all templates
  • Certificate of Completion
  • Tips and advice on being highly effective in the FDA regulated industry
  • One hour free practical consulting on your project

Course Outline

Focus on Software Testing Activities of the Following Standards

Hands-on exercises to build your expertise

21 CFR § 820.30
Quality System Regulations - Design Controls

ISO 13485
Medical Devices - Quality Management Systems

FDA General Principles of Software Validation,
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

ISO 14971
Medical devices - Application of risk management to medical devices

IEC 62304
Medical device software - Software life cycle processes

FDA Mobile Medical Applications Guidance

FDA Applying Human Factors and Usability Engineering to Medical Devices
IEC 62366-1
Medical devices - Part 1: Application of usability engineering to medical devices

Postmarket Management of Cybersecurity in Medical Devices

IEC 82304-1
Health software


Class Schedule

If you have 6 or more students, save time and money with our on-site instruction at your facility. Learn more by contacting us

Morning Session 9:00 a.m. - 12:00 p.m.
Lunch 12:00 - 1:00 p.m
Afternoon Session 1:00 - 4:00 p.m.