2 Emerging Medical Device Manufacturers Partner with ComplianceQuest to Implement AI-Driven Quality Management System

ComplianceQuest’s modern, cloud-based, AI-driven EQMS solution built on the Salesforce platform has assisted several small sized companies and startups in reaching their full potential. This e-book examines two such success stories, in which ARC-One and ITEK leveraged ComplianceQuest’s market-leading QMS to achieve their quality and regulatory goals.

ARC-One is a software medical device manufacturing company headquartered in Miramar, Florida. Founded as a collaboration between the Red Cross and One Blood. The software tracks each unit of donated blood from collection to transfusion, improving the blood donation process, and ensuring safety.

Challenges:

• New venture required 100% regulatory compliance on day one
• Short roll-out time
• Extensive customization needs
• Highly regulated industry

ITEK is a shelter manufacturing company located in Costa Rica with services ranging from logistics and distribution management to manual and automated manufacturing. Operating in Costa Rica’s coveted Free Trade Zone, it offers competitive advantages to medical device companies that are launching, expanding, or relocating their manufacturing operations.

Challenges:

• Start-up shelter manufacturing company
• Quality management systems and procedures not yet established
• Building customer confidence and trust
• Achieving regulatory compliance

To discover the whole transformation journey of these two new companies, download this success story e-book.