Orthopedic medical device company in North Texas bumps into the regulatory maelstrom.
Fusion Helps Medtech Company Get Ready FDA Audit
Entrepreneur in rehab encounters the perils of “guess what works” because it is tricky treating a patient with exactly what they need. One creative spark later, a company is formed with a device to measure the stress/strain/motion of a patient. Until you encounter the regulations and fine print to sell products in this space.
Fusion augmented the implementation of quality systems, staff training, and getting the whole enterprise ready for its first FDA audit.
One audit later, the team was ready, willing, and able with full documented procedures in place.
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