Course Description

Standalone Software Under the Medical Devices Directives

Course Description:

This informative course provides a detailed introduction to standalone software for medical devices. Based on examples and with links to regulations, the course introduces the learner to:

  • What is standalone software
  • EU requirements for software running on medical devices
  • Software as a stand-alone medical device
  • How the recent FDA draft guidelines on mobile medical apps can be complementary to the EU requirements
  • The EU MEDDEV guidelines for standalone software
  • Expected developments in the recast of the MDD

A brief Question & Answer section completes this overiew course.

Learning Objectives:

Upon completion of this course, trainees will be able to correctly and successfully:

  • Comprehend the regulatory framework relating to standalone software as medical devices
  • Participate in the evaluation of the organization’s need for compliance with regulations related to standalone software

Who Should Enroll:

Development managers and engineers who want to update their knowledge about the regulatory requirements surrounding standalone software. Regulatory and quality managers involved in compliance issues related to standalone software. Executive management who wish to oversee compliance-related aspects of standalone software as medical devices.

Prerequisite Knowledge/Requirements:

Participants should have sound work experience related to compliance of medical devices software. It is strongly recommended that participants possess a basic understanding of the knowledge areas covered within the following

WMDO training course:

  • ID 227 - Understanding Software Validation

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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