• Present CE Mark Approval Process for Medical Devices
• Biocompatability, Sterilisation, Clinical Data
• Medical Device Quality Systems Audit
• Key Documents – e.g. ISO Standard Documents, MEDDEVS

What are Standards?
• The component parts
• The value and use of standards
• Compliance, why and how

How Standards change:
• The standard Development process
• NSAI role in changing standards

How to find a standard:
• NSAI site and links
• Emerging standards
• Published Standards
• NMCs (National Mirror Committees)

Brian Byrne, Executive Project Development Director, Global Aid Shannon / Advisory Board Member, Atlantic Way

Global Aid Shannon is a unique international humanitarian aid initiative being developed at Shannon with partner organisations based in Ireland and the United States. The initiative will feature a specialist freight logistics hub at Shannon for airlifting high-value aid supplies and personnel to disaster sites around the world, and will be supported by qualified staff in an array of disciplines that are relevant to humanitarian aid and community rebuilding.

Formed around a not-for-profit partnership of high profile stakeholders, the project will lend particular emphasis to the use of cutting-edge technologies that will give Shannon a unique offering to Non-Governmental Organisations, and international aid agencies in making the relief chain more efficient.

Established in 2005, Atlantic Way is a voluntary movement comprising key influencers and organisations along Ireland’s western corridor - coming together to further develop the region’s resources and to focus on showcasing its strategic strengths. Atlantic Way enables its 1,000 individual and corporate members to avail of networking and communication opportunities with stakeholders throughout the region and beyond.

Claudia Carr, Supply Chain Management and Operational Excellence Lead, BearingPoint Consulting Ireland

Claudia will deliver a presentation on ‘The Strategic Importance of Supplier Management’. She will also outline the results of BearingPoint Consulting’s latest sourcing monitor, which is due to be published in July 2011.

Peter will deliver a presentation on IEA Life Sciences Ireland’s new supply chain initiative that will target the pharmaceutical and medical device sectors. The project entitled 'Security of Supply and Patient Safety through Good Distribution Practice' in the Life Sciences Sector is a part European funded initiative, which will involve the creation of a knowledge portal. This knowledge portal will host a suite of cutting edge modules on a range of supply chain issues selected by the members of an industry-led Technical Cluster. It will also evolve in to an important industry communication platform for the life sciences sector in Ireland.