There are many complexities about the way the FDA or the medical device regulations are structured, both in the United States and globally.
It takes the experience to understand the best steps to get through those complexities. Over time we have been able to generate the experience, resources, and tools required to execute successful regulatory strategies including 510K and PMA clearances.
Rob Ball (Genesis CEO), previously ran Regulatory Affairs at Tornier (a publicly traded orthopedic company). Two of our other founders, Jeff Ondrla and Don Running also has extensive experience in the regulatory process, particularly in the orthopedic space.
Our team’s experience includes:
- Class I Medical Devices
- Class II Medical Devices
- Class III Medical Devices
Additional Medical Device Regulatory Resources
We are also able to augment our experience with external experts that are deeply engaged with the company. These experts spend a very material part of their professional time with Genesis.
Another strategic regulatory advantage we bring is a relationship with an industry-leading and highly-skilled animal scientist. This professional is very engaged with Genesis and has done many animal studies for us.