FDA Registration Case Study

Device-Registration
CHALLENGE:
A small start-up company had achieved their second round of funding to commercialize custom dental surgical guides. The company manager had no prior experience in the medical device industry and very limited bandwidth. The company also had no supporting quality or regulatory resources. Facing the task of registering the product and company with the FDA, the company president reached out to AlvaMed to ensure that the registration was completed accurately.


APPROACH:

AlvaMed brought the needed regulatory support to the client. A small (less than $1,000) project was approved within a week. AlvaMed reviewed the company’s products and identified that the company played the role of both specification developer on some products and manufacturer of others. AlvaMed processed the registration for the company.


RESULTS:

AlvaMed completed the registration for the company and coached the company president in the FDA registration process. Subsequently the company has successfully launched the products and continued to maintain their registration without the need of additional support.