Manufacturing Success

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Manufacturing for a VC-Funded Firm

The Challenge

A venture capitalist-funded company had licensed a patented
device. Since the company staff did not have medical device manufacturing expertise, they sought a company that had an
FDA-compliant GMP system and the expertise to fabricate the
complicated device. Actuated Medical was selected due to our
ISO 13485 certification, experienced staff, and capabilities.

Our Approach

After agreements were signed, Actuated Medical research engineers completed component and assembly drawings. The drawing package was released for production, and pilot manufacturing was initiated for the device with the intent of seeking 510(k) market clearance.

The Results

Once the process for making the device was validated, a 510(k) market clearance was submitted to the FDA. Actuated Medical is scaling the manufacturing process to 6,000 units per year and 10,000 disposable units. Actuated Medical is awaiting FDA clearance, and the VC-funded company is working on the details of sales, marketing, and distribution rollout.

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