Course Description

Understanding Software Validation

Course Description:

It covers the following topics:

  • Basic concepts of software validation
  • Categories of medical device software
  • Examples of software validation with links to regulations
  • Key international regulations for software-related medical devices

Additionally, this course illustrates a framework for Software Validation and details the required documentation needed for manufacturers to develop medical devices with software validation.

Watch the Course Trailer:



Learning Objectives:

Upon successfully completing this course, trainees will be able to:

  • Comprehend the regulatory framework related to medical device software validation
  • Participate in the evaluation process of software-related medical devices

Who Should Enroll:

Development managers and engineers who wish to update their knowledge of regulatory requirements and methods for software validation, regulatory and quality managers responsible for implementing and maintaining validation programs, and executive management employees who wish to oversee compliance-related aspects of software validation are all encouraged to enroll in this course.

Prerequisite Knowledge/Requirements:

Participants should have at least one year of work experience with medical devices, including software.

The following courses are strongly recommended:

  • The Design, Development and Industrialization of Medical Devices (ID 183) – Under construction
  • ISO 14971: 2007 Review (ID 78)
  • Preparing Risk Management Files & Which Techniques Apply (ID 83)
  • Importance of Technical Standards in the Medical Device Sector (ID 185)
  • Overview of US FDA Quality System Regulation (ID 118)
  • ISO 13485ISO 13485: Medical Device Quality Management Systems Requirements for Regulatory Purposes(ID 196)

Subject Matter Expert:
Dr. Ivan Vecerina

54 min

Related resources:

Case studies:

Basic Account: € 216.00
Premium Account: € 162.00

Last update - 03/12/2018:

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