This audio conference presentation highlights the new European Union requirements for software systems arising from the latest amendments to the Medical Devices Directive (MDD). The presentation focuses on how software should be designed to ensure the repeatability, reliability and performance of systems according to the intended use. Our speaker also addresses how, in the event of a single fault condition in the system, appropriate means can be adopted and documented to show that risk has been eliminated or reduced as far as possible. The presentation also covers how to establish suitable documentation to demonstrate compliance and satisfy Notified Body reviewers.

This audio conference covers:

• Overview of the MDD software requirements
• Overview of the extent of documentation to show compliance to EU software requirements
• Importance of software requirements, specification, architecture and detailed software design
• Importance of traceability from software requirements to test plan and results
• Examples of software risk control measures

About the speaker:

Poul Schmidt-Andersen has spent 17 years as chief engineer in the field of R&D for active medical devices such as software for cardiac output computers, neonatal monitoring, resuscitation and diathermy equipment. In 1994, Poul started the DGM – the Danish Medical Devices Certification Organization, a Notified Body for the IVDD and MDD Directives. As managing director of DGM he was responsible for its development until July 2001 when he founded his own consultancy firm, Danish Medical Devices Consulting. Prior to leaving DGM he acted as vice-chairman for the EU Notified Bodies Medical Devices Group, and worked as a convener of the newly finished recommendations on software requirements. Poul has reviewed many software projects with respect to the US/FDA guidelines for software validation and the EU harmonized standard EN 62304, and has successfully completed several EU registrations of software-driven blood imaging equipment and infusion pumps.

Who should attend?

• Software Project Managers
• Software Engineers
• Quality Managers
• Software Test Managers
• Regulatory Affairs Managers