MEDICAL DEVICES

What Schlötter (Irl) Ltd offers the Medical Devices Sector

Market background

Ireland, which is home to 15 of the World's top 25 Medical Technologies companies, is a proven Global Medical Technology manufacturing location.

Medical Technologies- Sub-Sectors

• Cardiovascular and Cardiac Rhythm
• Management
• Orthopaedics
• Diagnostics
• Ophthalmic
• Other key medical device sub-sectors

Regulatory Environment

Highest Quality & Regulatory Standards

Medical Technology companies based in Ireland operate to the highest International quality standards e.g. European, US and Japanese regulations.

The National Standards Authority of Ireland (NSAI) is a globally experienced notified body, with a worldwide clientele and there is mutual recognition of product approvals between member states in the European Union.

The Irish Medicines Board is responsible for generation and issuance of Certificates of Free Sale for Class 1 medical devices, custom made devices, systems and procedure packs and all in-vitro diagnostics medical devices. Once the devices are CE marked they can be freely marketed anywhere in the EU and EEA without further control.

What Schlötter Ireland offers to the Medical Devices Sector

Schlötter Ireland’s long established expertise in chemical sourcing, chemical handling, chemical blending, testing, packaging, labelling and supply chain management offer a seamless contract manufacture solution to Medical Device companies who wish to scale up and out-source their own chemical IP process requirements from R&D to scale up to full global production requirements, and fully address any issues that are posed by the scale up process while complying with the stringent Regulatory Environment applying to various global export markets.

For further details please contact:

Sean Coughlan Key Account Manager @ scoughlan@schlotter.ieor + 353 45 447441

For more information on Medical Devices contact Schlötter Ireland