Empirical Machine, part of the family of Empirical companies that supports medical device development, is pleased to announce it is now registered as a contract manufacturer in the U.S. Food and Drug Administration Registration and Device Listing Database. The designation confirms that Empirical Machine meets the rigorous standards set by FDA to manufacture medical devices.
“We’re thrilled we’ve achieved this milestone as a company,” said Dawn A. Lissy, president. “For the past decade, we’ve focused on providing exceptional service to generate prototypes and fulfill small-batch manufacturing projects of our clients’ medical devices. Now we can expand our services and leverage our 100-plus years of combined manufacturing experience to machine finished medical-grade parts for our clients.”
Empirical Machine, which started in 2008, is an ISO 9001 and ISO 13485 facility capable of crafting prototypes and test fixtures for medical device development. Lissy added the machining company to support clients of Empirical Testing Corp., the mechanical testing company she founded in 1998. Because of the connection to mechanical testing as well as Empirical Consulting, which specializes in regulatory support, machinists and operators are committed to a high level of precision manufacturing throughout the production cycle.
“This machine shop really grew out of the need we were seeing from a broader industry perspective,” Lissy said. “When clients come to us, they know we have testing, regulatory and manufacturing experts in-house who have decades of experience in the industry and are dedicated to ensuring our clients’ success.”
For more information about Empirical Machine, please visit
Empiricaltech.com/machine.