Managing Medical Device Software Projects - Part Of The Medical Device Training Academy Series

Following the success of our Medical Device Training Academy series: Medical Device Training days in 2009, we are once again providing a series of events under the Academy

Is your Software a Medical Device and is it Correctly Classified?

Course Summary

The course will provide valuable assistance and advice to all MDD regulated companies reviewing the status of their product range with respect to the new directive.

Key Topics to Include:

• The Medical Devices Directive 93/42/EEC Published as Directive 2007/47/EC - Implications for Software
• Overview of Software and Medical Standards
• Software and IEC 60601-1 ed 3
• Software Life Cycle Processes & IEC 62304:2006 Medical Device Software
• Risk Management ISO 14971 & ISO 62366 – Application of UsabilityEngineering to Medical Devices
• Developing a Technical File for a Medical Software Project
• Auditing a Software Project - Internal and External Auditing Techniques
• Q & A Session

Who Should Attend:

Senior Management responsible for operational and quality systems (‘system owners’) regulatory, clinical and IT professionals working in the health care, manufacturing and medical device markets.

• QA/RA Directors, Managers and personnel
• Consultants charged with creating or evaluating software
• Software personnel programmers, developers, verification & validation engineers
• Project managers and others responsible for bringing systems online in a compliant manner
• Quality auditors responsible for auditing and evaluating medical software

Tutor:
Peter Pringle, Consultant Engineer, Intertek

Please note,The Cavendish Hotel, which is the recommended accommodation for this event, is a 15-20 minute walk from the MWB Cavendish Square venue.