Medical Device Software Testing in a Nutshell


FREE 1-hr webinar below from NOPMARK instructor, hosted by ASTQB, gives you an introduction to the Medical Device software testing

Software testing is a required activity in the medical device industry. Regulatory requirements and the risk of injury to the patient, user, and environment make this a mandatory and highly scrutinized task. While the basic software testing process and techniques apply, there are definite differences.

This 1-day course is offered in conjunction with the 3-day ISTQB Foundation Level course at a discounted price.


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 one-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, and other applicable international and regulatory standards as they apply to  software testing activities and deliverables.


Course Tuition Includes

  • Instructor-led one-day course

  • Course notebook with all slides

  • 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

Why Medical Device Testing is Different

History of Regulations

Focus on Software Testing Activities of the Following Standards:

  • 21 CFR § 820 and 820.30, Quality System Regulations - Design Controls

  • IEC 62304, Medical device software - Software life cycle processes

  • ISO 13485, Medical devices - Quality Management Systems

  • Validation of Production Software and QMS

  • ISO 14971, Medical devices - Application of Risk Management to Medical Devices

  • FDA General Principles of Software Validation, Validation of Production Software and QMS

  • Mobile Medical Applications

  • Software as a Medical Device - SaMD

  • Cybersecurity, Post and Pre-Market

  • Digital Health and a look into the Future

How Medical Device Testing is Different:

  • Objective Evidence

  • Evidence of document reviews

  • How does Agile work with medical device software development and test

  • Different types of test techniques when applied to medical device, e.g. Session-based testing

  • Summary of all the changes related to Test Plans

  • Summary of all the changes related to Test Procedures

  • Summary of all the changes related to Test Reports

  • Summary of all the changes related to Defect Management


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.