Ceram, the independent materials technology company, 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.
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. We then deliver credible data with full documentation and ongoing technical support.
“We congratulate Greatbatch Medical on achieving FDA acceptance and believe that the whole process has highlighted the value of working so closely together.”
Valéry Barbour, Quality Assurance - Customer Relation Manager, at Greatbatch Medical said:
“I would like to thank all of the Ceram team that has worked on this file during the last few months for its great involvement in the project, strong expertise and excellent responsiveness.
Working closely together allowed us to develop a comprehensive testing programme to fulfil FDA requirements for the submission of a hydroxyapatite coating master file.
“Ceram’s responsiveness to our questions really moved along the review of the file by FDA and we have really appreciated it! It was a challenging key milestone that we have successfully managed thanks to our new partnership.”
For more information about Ceram’s regulatory approval service visit www.ceram.com/reg-approval