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Clinical Evidence

“The Clinical Evidence Reports prepared with assistance of Brandwood Biomedical were complimented by the TGA auditor and certainly smoothed the path of our re-certification.” Australian Supplier of Disposable Medical Devices

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No need for a recall

When is a non-compliance still compliant with regulations? A distributor of medical disposables approached us after discovery of an unauthorised substitution of an active ingredient in a skin cleaning product. …

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Cleaning up the mess

When it’s all going wrong you need a competent local friend.  A large US multinational had entered the Chinese market by engaging a local distributor.  The distributor had offered regulatory…

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Quality - Fast

From a standing start to global approvals in 6 months.  A small Australian start-up with only 3 employees were developing a complex software controlled diagnostic device and required a very…

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Going nowhere fast?

No Orient express here.  We were approached by a European Multinational exporting surgical dressings to China.  One of their submissions for a Class III dressing had been stalled in the…