Fertility Monitor

 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. 

Scope of Work – Fertility Monitor

•  Agency/compliance testing
• Mechanical design
• Creation of a well-developed quality and documentation system
• Special emphasis on product tracking and traceability
• Compliance of recognized medical standard
• Design for manufacturability