Medical Device Software Testing-
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 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
ALL-YOU-NEED DOCUMENT TEMPLATES FOR ANY TYPE OF SOFTWARE TESTING IN THE MEDICAL DEVICE INDUSTRY
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
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
Medical Devices - Quality Management Systems
FDA General Principles of Software Validation,
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Medical devices - Application of risk management to medical devices
Medical device software - Software life cycle processes
FDA Mobile Medical Applications Guidance
FDA Applying Human Factors and Usability Engineering to Medical Devices
Medical devices - Part 1: Application of usability engineering to medical devices
Postmarket Management of Cybersecurity in Medical Devices
If you have 6 or more students, save time and money with our on-site instruction at your facility. Learn more by contacting us email@example.com
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.