Case Study

Benefits of a Boutique Product Development Partner for a Class III Medical Device

Benefits of a Boutique Product Development Partner for a Class III Medical Device

Benefits of a Boutique Product Development Partner for a Class III Medical Device CASE STUDYThe Challenge A global developer of medical technology was struggling with end-of-life component issues on their flagship product, a class III medical device. The product required FPGA development, new boards, and updates to the system to meet current 60601 and 62304 standards. Like many large companies, their internal bureaucracies and infrastructure can slow projects. They needed a partner who could address the issues efficiently and quickly, and also had a track record of engineering excellence. The medical manufacturer solicited 3 large contract manufacturers and one boutique product development provider, Resolution. As part of the solicitation, each company had to undergo and pass a

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