Software Processes for Medical Device, Diagnostics & Healthcare Technologies: Concept to Validation

Date : Tuesday 30.08.05 - Thursday 03.11.05

Details : BioMedIreland* invites you to a series of workshops planned to address best practices and regulatory compliance for the development of software applications and components.
In building a technical file for FDA approval or a design history file for CE marking, the software components are often the most complex and sensitive to process compliance. The software project management discipline is very challenging especially within highly regulated industries such as medical devices, diagnostics and healthcare technologies.

Dr Fergal McCaffery – Centre for Software Process Technologies, will chair this series. The series will be delivered with the following programme:

Workshop 1: Requirements Engineering

Prof Elizabeth Hull – University of Ulster
IBM Consulting
Ken Jackson – Telelogic
Clear, well-defined and thorough requirements specifications are the foundation of any successful project and this subject is the focus of workshop 1.
Note: A free copy of Prof. Hull’s book will be provided for all attendees
Date: 30 August 2005
Time: 10.00am to 4.30pm
Venue: Crowne Plaza Hotel, Dublin

Workshop 2: Software Project Management

Peter Jordan – Sensible Standards
This workshop will focus on project planning, project monitoring and control, regulatory compliance and risk management.
Date: 06 October 2005
Time: 10.00am to 4.30pm
Venue: Radisson Hotel, Belfast

Workshop 3: Software Verification and Validation

Fran O’Hara – Insight Testing Services
This workshop will focus on software verification and testing, including in-house and 3rd party software and testing processes to mitigate high risk elements.
Date: 03 November 2005
Time: 10.00am to 4.30pm
Venue: Crowne Plaza Hotel, Dublin

Registration Details
Fee: Single Workshop - £149 pp
Workshop series (3 events) - £295 pp

Refreshments and lunch will be served.
For all queries on the event, please call the event organiser:
Michelle McCarry, Tel: +44 (0)28 9073 7947
To register, please email: michelle@biobusinessni.org

* BioMedIreland is an all-island network, established by IMDA, IBIA, BioBusiness NI and InterTradeIreland to facilitate & enhance the competitive positioning and innovation capabilities of the health technology and biotechnology sectors on the island of Ireland.


Location : Crowne Plaza Hotel, Dublin; Radisson Hotel, Belfast

Cost:
Workshop series (3 events) - £295 pp

Contact:
For all queries on the event, please call the event organiser:
Michelle McCarry, Tel: +44 (0)28 9073 7947
To register, please email: michelle@biobusinessni.org

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