Medical Device Software Verification & Validation
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 hand-on course focused on preparing you to apply your ISTQB Foundation Level in Software Testing knowledge to a FDA regulated industry.
The three-day Medical Device Software V&V 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.
At the conclusion of this 3-day course, you will be able to:
Identify the different types of software regulated by the FDA and interpret the latest FDA regulations, guidelines and International standards applicable to medical device software.
Discuss software level of concern, software safety classification, and use it to focus software verification & validation activities.
Efficiently and effectively apply the different requirements for software verification & validation to devices, manufacturing & quality system software.
Create a software V&V plan, test procedure, and software V&V summary report that documents software verification & validation activities and complies with regulatory requirements.
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
ALL-YOU-NEED TEMPLATES FOR ANY TYPE OF SOFTWARE TESTING IN THE MEDICAL DEVICE INDUSTRY
Course Tuition Includes
Instructor-led three-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
You will work on a project with a real medical device, designed to help you determine software level of concern, software safety classification, define a software verification & validation strategy, write a software verification & validation plan, create software verification & validation test procedures and test cases, and write a software verification & validation summary report. Overall, you will learn how to create these types of documents and activities while also learning the regulatory requirements and expectations for software used in the medical device industry.
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
General Principles of Software Validation
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Postmarket Management of Cybersecurity 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 Software as a Medical Device (SaMD) Guidance
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.