Course Description

Standalone Software Under the Medical Devices Directives

Course Description:

This course provides a detailed introduction to standalone software for medical devices.

It covers the following topics:

  • Definition of standalone software
  • EU requirements for software running on medical devices
  • Software as a standalone medical device
  • How the recent FDA draft guidelines on mobile medical apps complement the EU requirements
  • EU MEDDEV guidelines for standalone software
  • Expected developments in the MDD recast

At the end of this course there is a brief question and answer section.


Watch the Course Trailer:



Learning Objectives:

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

  • Comprehend the regulatory framework related to standalone software as medical devices
  • Participate in the evaluation compliance process with regulations related to standalone software

Who Should Enroll:

Development managers and engineers who wish to update their knowledge about regulatory requirements related to standalone software, regulatory and quality managers involved in compliance issues related to standalone software, and executive management employees who wish to oversee compliance-related aspects of standalone software as medical devices are all welcome to participate in this course.

Prerequisite Knowledge/Requirements:

Participants should have sound work experience related to medical device software compliance.

The following course is strongly recommended:

  • Understanding Software Validation (ID 227)

Subject Matter Expert:
Erik Vollebregt

40 min

Release date:

Related resources:

Case studies:

Peer review:
Michael Maier

Basic Account: € 160.00
Premium Account: € 120.00

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