PRLog - Oct. 4, 2012 - Ceram is launching two new services at Medtec Ireland which is taking place in Galway on 9 and 10 October – their Regulatory Approval Package and their Polymer Consultancy & Testing service.
Materials experts from Ceram will be on Stand 204, to talk about the two new services and about the many testing and consultancy services that they provide to medical device manufacturers and suppliers.
Dr. Xiang Zhang, Principal Consultant, Medical Materials & Devices, and a world-renowned expert in polymers says:
“In addition to the chemical, physical, microscopy, mechanical and bulk analysis that we provide, the focus of the new polymer offering is on consultancy - helping manufacturers to solve product failures quickly and definitively, to select the right polymers for the right application and to develop innovative new products to meet the needs of the future.”
Ceram is also launching its Regulatory Approval Package, designed to help manufacturers or users of Hydroxyapatite gain approval of their FDA 510(k) submissions.
Ceram will put together a complete testing package, providing analysis, full documentation and ongoing support, to help companies secure approval. Ceram has recently helped Greatbatch Medical, providers of critical technologies used in medical devices, to gain FDA acceptance of its hydroxyapatite coating master file by providing all the necessary testing on the coating for a 510(k) implant submission.
Ceram is an independent, international materials technology company that focuses on innovation, sustainability and quality assurance of materials.
Headquartered in Staffordshire, UK, and with approved laboratories around the world, Ceram solves product and process challenges across a range of materials to help clients improve performance, comply with regulations and develop their sustainability performance in order to gain a competitive advantage and increase profitability.
Ceram operates in a wide variety of sectors around the world.
For further information, please contact:
Enquiries +44(0)1782 764428
UK customers 0845 026 0902
Fax +44(0)1782 412331