Overview
The client, a medical device company based in the US, known for delivering state-of-the-art medical solutions, was in search of a technology partner experienced in crafting healthcare solutions to facilitate their entry into the US market. ACL Digital designed an FDA-compliant pump console life support system. This system is dedicated to conducting extracorporeal blood circulation procedures, catering to licensed physicians and specialists.
Challenges
Unavailability of a standalone pump console system compliant with FDA Class C regulation
Lack of in-house experience in developing regulatory compliant solution
Benefits
- Delivered IEC 62366 and FDA Class C compliant solution enabled the client to penetrate the US market with their standalone pump console solution
