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Orchid Design Has Been Selected to Participate in FDA’s Submission Tracker Pilot Program


Shelton, CT – Orchid Design has been selected by the FDA to be the sole regulatory consulting firm to participate in their submission tracking initiative. The FDA is piloting a web-based program to track the status and key details of 510(k) submissions in an effort to add transparency and eliminate confusion surrounding the often misunderstood “FDA Review Clock.”

Kellen Hills, Senior Quality and Regulatory Consultant for Orchid Design comments, “The insights gained from working directly with the FDA on this project will allow us to efficiently and effectively navigate the regulatory submission process, as well as bring important issues to the FDA’s attention from a perspective they may otherwise not have considered in the development of the Submission Tracker program.”

Orchid Design will be working alongside two of the largest medical device manufacturers to collaborate with the FDA on this project.

About Orchid Design: 
Orchid Design, a division of Orchid Orthopedic Solutions, is the orthopedics industry leader in innovative surgical device Design, Development and Regulatory submission services. Utilizing their ISO 13485 certified product development process, Orchid Design partners with device companies to help bring their ideas to life and streamline the pathway to commercial launch. The company has two design centers located in Shelton, CT and Memphis, TN, focused on the orthopedic medical device market. For more information about Orchid, visit the company’s website at www.orchid-ortho.com.

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