Bringing a Device From Concept to Market

A medical device start-up aimed to bring their innovative device to the global market, focusing on the United States and European Union. The client faced the challenge of navigating complex regulatory environments, as their device was classified under the highest risk category in both regions. This classification required substantial clinical data and rigorous testing to meet regulatory standards, posing a significant hurdle for the start-up. The start-up also needed to develop a comprehensive quality system to comply with both FDA regulations and ISO 13485 standards. 

Overcoming these challenges was critical for achieving regulatory approvals and entering the market. Within less than three years, the company successfully obtained FDA approval and CE Marking, allowing them to enter the US and EU markets. This success was followed by market entry into other international regions, including Canada and Australia.

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