Project Description
Overview
We provided the manufacturing for fertility monitoring devices (FDA Class 1 medical device) for a renowned women’s health diagnostic producer that needed a low cost, high quality contract manufacturer. The company was aiming for new markets including Asia.Challenges
- Required well-developed quality and documentation system
- Special emphasis on product tracking and trace-ability
- Turnkey manufacturing partner with capability for compliance of recognized medical standard
- Short implementation time
Services Performed
- Design for manufacturability
- Agency/compliance testing
- Product trace-ability and documentation control
Results
- Successful launch of device in short time frame meeting customer’s quality and trace-ability standards