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.
Acquired by C.R. Bard in 2003, now BD One phone call of warning. Nine auditors on site. A passed qualification that made us an FDA-registered medical manufacturer.
- Client
- C.R. Bard (now BD)
- Industry
- Medical
- When
- Early 2000s
- Made in
- Riviera Beach, Florida
- Services
- PrototypingCNC machiningComponent manufacturingAssembly
The challenge
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.
What we did
- Introduced the founders to Ted, an experienced operator who built the company up for sale
- Manufactured and serviced Sure-Point devices and accessories for Amertek Medical and Alton Design from 1997 to 2003
- Hosted a nine-person qualification visit covering attorneys, management, and quality
- Registered with the FDA and built the quality system to support a major medical OEM
The result
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."
The MTE family, on the Bard visit
What this means for your part.
Audit-ready on short notice
Our systems held up to a nine-person OEM qualification with attorneys, management, and quality in the room.
Decades on one product family
We've built and serviced the same devices since 1997, through two owners, and still ship the loaner kits today.
Build and service under one roof
The people who machine the parts are the people who repair them, so nothing is lost between build and field.
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