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

Duration:
40 min

Release date:
05/10/2012

Related resources:
Yes

Case studies:
No

Peer review:
Michael Maier

Price:
Basic Account: € 160.00
Premium Account: € 120.00

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