Empirical Machine Earns FDA Contract Manufacturer Registration

Empirical Machine, part of the family of Empirical companies that supports medical device development, is now registered as a contract manufacturer in FDA’s Registration and Device Listing Database.

The designation confirms that Empirical meets 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 is an ISO 9001 and ISO 13485 Certified facility capable of crafting prototypes and test fixtures.

Additional capabilities include:

  • Swiss and conventional turning
  • 3-, 4- and 5-axis milling
  • Grinding
  • Finishing and inspection
  • Stainless steel, UHMPE and PEEK manufacturing

Empirical is an OMTEC® 2018 exhibitor.

Source: Empirical Machine