Fertility & Contraception Monitors

//Fertility & Contraception Monitors

Project Details

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ISO 13485
Fertility & Contraception Monitors2019-08-14T10:20:42-04:00

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

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