FDA Compliant Design For Surgical Trays

Executive Summary

The client is a European company in a highly competitive and fast-moving medical instruments business. Their primary challenge was to have tray configurations designed with short lead times, to meet production and delivery schedules. End-customers define custom instrument kit contents. Our client now need a custom tray to accommodate them with optimal space utilization with ergonomic and aesthetic considerations.

The key success factor for business was to have a custom mechanical layout ready for production within 12 hours of the instrument kit selection. This was possible with a partner through a global delivery setup, that understands the nuances of production complexities, material selection, ergonomics and precision packaging.

The client was able to reduce the selection and design lead time to less than 24 hours, to enable a production and delivery schedule of less than 1 week.

Project Highlights

  • Flexible Case Configurations
  • Compatible to Multiple Tools
  • Easy Sterlization and Use
  • Optimial Space Utilization
  • FDA Class 2 Compliant Design
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