In the Hawaiian language, the Kōhola — the Humpback Whale — is more than just a magnificent creature. It is a symbol of protection, a navigator of the deep, and a guide through vast, often unpredictable waters.
In the world of Medical Device development, the “deep waters” are the thousands of pages of federal regulations, international standards, and audit expectations. For a startup, these waters can be treacherous. One wrong turn in your Design History File or a weak link in your Risk Management can stall a product launch for years.
I founded Kōhola Consulting to be that guide.
With 30 years of experience, I’ve seen where the hidden reefs are. I’ve helped companies navigate the complexities of ISO 13485 and the transition to the new FDA QMSR. My goal is to help you move with the same grace and power as the Kōhola—steady, sure, and always headed toward the goal.
At the end of the day, quality isn’t about the “Paper.” It’s about the Patient. We build the architecture that ensures your innovation reaches the people who need it most.
Chart your course: www.Koholaconsulting.com