Medical Device Software Testing-
FREE 1-hr webinar below from NOPMARK instructor, hosted by ASTQB, gives you an introduction to the Medical Device software testing
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.
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, IEC 62366-1, 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
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
IEC 62366-1, Medical devices - Part 1: Application of usability engineering to medical devices
Cybersecurity, Post and Pre-Market
Digital Health and a look into the Future
How Medical Device Testing is Different:
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
If you have 6 or more students, save time and money with our on-site instruction at your facility. Learn more by contacting us firstname.lastname@example.org
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.