Challenge

The ZipE is an innovative knotless soft tissue repair implant invented by Dr. William F. Bennett (CEO of Ziptek LLC, a Florida based company) that provides a repair solution without the need of tying knots, it maximizes surface contact area, and provides an accelerated recovery of the patient. Ziptek LLC needed regulatory approval from FDA for entering the market, as well as Quality System in place to guarantee the safety and effectiveness of the device.

Solution

Bioana provided Ziptek with a global regulatory strategy, and worked in creating a robust Design History File that later was used for developing the 510(k) application for market clearance. Additionally, Bioana designed Ziptek’s Quality System Procedures that helped the company operate with quality as a mindset.

Results

Ziptek got FDA clearance in March 2017, just 6 months later after the submission, and has already begin selling. Bioana is currently helping Ziptek with Quality Assurance.

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