Sure-Point: the surprise audit that made us an FDA shop
From 1997 we built and serviced Sure-Point urology devices for Amertek Medical and Alton Design. When C.R. Bard acquired those assets in 2003, nine people showed up to qualify us, because the deal depended on it.
A urologist and his son had a device, the Sure-Point floor and table-mount systems, and needed a manufacturer who could take it from prototype to repeatable production. When C.R. Bard moved to acquire the Amertek and Alton assets, the deal depended on a qualified, active contract manufacturer. We had one phone call of warning.
- 01Introduced the founders to Ted, an experienced operator who built the company up for sale
- 02Manufactured and serviced Sure-Point devices and accessories for Amertek Medical and Alton Design from 1997 to 2003
- 03Hosted a nine-person qualification visit covering attorneys, management, and quality
- 04Registered with the FDA and built the quality system to support a major medical OEM
We passed. Bard acquired the assets at the end of 2003, we registered with the FDA in 2004, and we went on building and servicing the same Sure-Point devices for Bard. We still build and ship the Quick-Link loaner kits: one order, about 200 machined pieces.
"Without us knowing, their deal to sell the company was predicated on a real, qualified contract manufacturer."
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