02
Medtech Audit
Orthopedic medical device company in North Texas bumps into the regulatory maelstrom.
Fusion Helps Medtech Company Get Ready FDA Audit
BACKGROUND
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.
THE SOLUTION:
Fusion augmented the implementation of quality systems, staff training, and getting the whole enterprise ready for its first FDA audit.
THE OUTCOME:
One audit later, the team was ready, willing, and able with full documented procedures in place.
If you are a passionate, results-oriented change agent, we might be the perfect fit to work together. Our results are the most potent when collaborating with leaders committed to reaching greater levels of performance.