Challenge
The client needed a solution for developing a Class I medical device while navigating the complex landscape of textile sourcing, composite materials, and regulatory compliance.
EB’s Approach
EB provided full oversight of sourcing, development, and regulatory processes, ensuring the product met stringent FDA requirements. EB’s team leveraged their expertise in materials science and regulatory strategy to guide the client through each phase of development.
Outcome
EB’s efforts led to the successful launch of a highly engineered menstrual management product, delivering both functional innovation and compliance with medical device standards