Standalone Software Under the Medical Devices Directives
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.
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
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.
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