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Ceram launches regulatory approval package

Ceram, the international materials technology company, has launched a Regulatory Approval Service, designed to help hydroxyapatite users and manufacturers in the medical device industry gain FDA acceptance of their 510(k) submission.

The service includes a comprehensive and bespoke testing package that provides all the data needed to submit a master file to FDA. Using their wide range of analytical facilities, Ceram will produce credible, quality data and full documentation in support of the submission, fully backed up by ongoing technical support.

Richard White, Head of Testing at Ceram, said:

“Our aim is to take the guesswork out of the testing regime necessary for FDA submissions, by use our experience to put together all the testing (chemical, physical and microstructural) that is needed - the right type, the right number and to the correct determinations.

As well as pre-regulatory approval, we also provide post-regulatory approval packages to help give manufacturers piece of mind that they are meeting current regulations. The service includes independent sampling of product by us, both from within the manufacturing process and from the distribution chain each year.

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.

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.”
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