Bringing A Device From Concept To Market

A medical device start-up aimed to introduce its innovative device to the global market, initially targeting the United States and the European Union. The device was classified under the highest risk category in both regions, requiring extensive clinical data and rigorous testing to meet regulatory standards, which posed a significant challenge. Additionally, the start-up had to develop a comprehensive quality management system to adhere to FDA regulations and ISO 13485 standards.

Navigating these hurdles was essential for securing regulatory approvals and market entry. Within three years, the company achieved FDA approval and CE Marking, facilitating its entry into the US and EU markets. This success led to subsequent market entries in other regions, including Canada and Australia.