Research and development services and related consultancy services

Tender description

The Purpose of this Call for Expression of Interest is to Ascertain the Marketplace for Manufacture of Orthopaedic Device Prototypes and Products. On-site capabilities: 5-Axis CNC milling, CNC turning, Swiss type sliding head turning, Mass finishing, Electro-polishing, Laser marking, Laser welding, Plunge EDM, Wire EDM, Cleaning and Passivation, Honing, Assembly and Clean-room Assembly, Inspection and Test. On-site manufacture of very low volume prototype parts. Facility suitable for prototype production as part of a research project undertaking. CNC machining must be 5-axis, with timely access for device prototyping purposes on an ongoing basis. A specialisation and familiarity with orthopaedic product manufacture. Clean-room facilities are required to meet ISO Class 8 for cleaning and passivation and ISO Class 7 for Assembly and Packaging of products. These facilities must be available 24/7 to ensure appropriate manufacture and turn-around time. The facility must be fully ISO 9001.2008, FDA and ISO 13485 accredited. Evidence of successful FDA audits in pursuit of 510(k) customer submissions.