Ceram helps Greatbatch Medical gain FDA acceptance
Ceram has helped Greatbatch Medical gain approval its hydroxyapatite coating master file by providing the necessary testing.
In an effort to supply its French-produced coated devices marketed by its customers into the US market, Greatbatch Medical submitted a detailed hydroxyapatite coating master file to FDA in conjunction with the customer-submitted 510(k) submission.
Ceram developed a comprehensive testing programme to supply sound and complete data and analysis to support the submission.
Working with implant manufacturers and bone replacement material suppliers, Ceram offers both a pre- and post-regulatory approval service to the medical device industry.
Dr Richard White, Head of Testing at Ceram, said:“We are unique in that, thanks to our extensive analytical services, we can put together a complete testing regime for clients.
“Our aim is to take the guesswork out of what is needed to gain regulatory approval, by using our experience to put together all the chemical, physical and microstructural testing in a bespoke package.”
Ceram has added biocompatibility testing to the range of its services for the healthcare industries.
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