MANAGING MEDICAL
DEVICE SOFTWARE
PROJECTS ~ Is your
Software a Medical
Device and is it
Correctly Classified?

Conference Date: 14 Oct 2010
Conference Ref: TD N10-8510
Fee: £450 + VAT
Venue: MWB Cavendish Square, London, W1

Designed with SME customers in mind, our new training days deliver the high quality training that you have come to expect from Management Forum, at a more accessible price. When you download the brochure, details of this course together with others in the same series will be provided.

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 Usability Engineering 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 and 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 contact andrea.james@management-forum.co.ukif you wish to know more about the new Training Academy or click here to visit our Training Academy Blog.

Click here to register for this important Seminar.