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.

Upcoming Classes

 
 
 

Description

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

  • and more

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

Course Outline

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

ISO 13485
Medical Devices - Quality Management Systems

FDA Guidances
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

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

IEC 62304
Medical device software - Software life cycle processes

Digital Health
FDA Mobile Medical Applications Guidance
FDA Software as a Medical Device (SaMD) Guidance

 

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 info@nopmark.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.