Empirical

Colorado Springs,  CO 
United States
https://www.empiricaltech.com
  • Booth: 1643


Welcome to NASS! Gain & Maintain Clearance w/Empirical #1643

Empirical is your partner in bringing your medical device to the world market quickly and efficiently. We beat the industry average of time to clearance by 52 days. For 20 years, Empirical Testing Corp. has been a leader in mechanical testing for devices. Empirical Machine, now FDA registered & AS9100 compliant, offers manufacturing/protoyping solutions. Empirical Consulting provides regulatory solutions to clients all over the world. Our team of experts combined has 100+ years of industry experience.

We’re your one-stop solution for a quick, efficient path to market. We provide a comprehensive solution for consulting, testing, manufacturing and validation services in the U.S and abroad. Our proven processes help you to navigate the ever-evolving path of regulatory approval. We hold the largest scope of accreditations for medical device testing methods in the United States.

The Empirical family of companies works with your team to help you gain and maintain regulatory clearance or approval. We're committed to your success.

Brands: Full-Service Precision Manufacturing & Prototyping, ISO 900, ISO 13485, FDA Registered, 3, 4, 5-axis Milling, Swiss Lathe, Medical Device Testing, RA/QA Consulting


 Press Releases

  • 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.
  • Empirical Celebrates 20 Years of Service in Medical Device Industry

    Colorado Springs, Colo. – In celebration of two decades years of service and the clients who’ve supported its growth, the Empirical family of companies is hosting a 20th Anniversary Celebration and Pig Roast Aug. 3-5. Because roasting pigs just somehow goes with mechanical testing, regulatory consulting and manufacturing/prototyping for the medical device industry.

    Not really. But kinda, at least for the Empirical gang. Founders Dawn and Chris Lissy used to hold pig roasts in their back yard in the late 1990s in Cleveland, Ohio. That was back when they were the only two employees in the company. It’s since grown to three companies in Colorado Springs, Colorado, that offer comprehensive solutions clients need to get their devices to market once the design is complete. So to celebrate how far they’ve come, they’re hosting a celebration that harkens back to their roots.

    “We just wanted a way to get together with clients and colleagues we’ve come to know over the past two decades – who are also friends – and show our appreciation for everyone who’s been part of our success,” said Dawn Lissy, president and co-founder.

    For those interested, Empirical is offering two education workshop sessions Friday, Aug. 3 covering the FDA’s new expectations for biocompatibility and testing of 3D printed materials. Friday will wrap up with a tour of the test lab and manufacturing facilities along with a ribbon cutting ceremony to commemorate the 20 years of service. Saturday, Aug. 4 is the pig roast and barbecue at the Western Museum of Mining and Industry. On Sunday, groups will embark on fun activities in the Pikes Peak region, such as hiking and beer tasting.

    When Empirical Testing Corp. launched in 1998, its two employees – newly married Dawn and Chris Lissy – worked on a single test from a garage. They moved to Colorado Springs in 2004 to accommodate the company’s expanding clientele. It now employs 33 team members   supporting 38 test frames and 10 CNC machines. Ten years after founding ETC, the Lissys launched Empirical Machine to meet the prototyping and precision manufacturing needs of their clients. Five years after that, Empirical Consulting was formed to address regulatory and quality concerns for that ever-growing client base of medical device developers.

    “This has been such an amazing journey for us,” Lissy said. “We’ve come so far thanks to an amazing team of experts and clients who appreciate our dedication to ensuring their satisfaction and ultimately, patient health.”

    For more information, visit www.empiricaltech.com.

  • Empirical Celebrates 20 Years of Service in Medical Device Industry

    Colorado Springs, Colo. – In celebration of two decades years of service and the clients who’ve supported its growth, the Empirical family of companies is hosting a 20th Anniversary Celebration and Pig Roast Aug. 3-5. Because roasting pigs just somehow goes with mechanical testing, regulatory consulting and manufacturing/prototyping for the medical device industry.

    Not really. But kinda, at least for the Empirical gang. Founders Dawn and Chris Lissy used to hold pig roasts in their back yard in the late 1990s in Cleveland, Ohio. That was back when they were the only two employees in the company. It’s since grown to three companies in Colorado Springs, Colorado, that offer comprehensive solutions clients need to get their devices to market once the design is complete. So to celebrate how far they’ve come, they’re hosting a celebration that harkens back to their roots.

    “We just wanted a way to get together with clients and colleagues we’ve come to know over the past two decades – who are also friends – and show our appreciation for everyone who’s been part of our success,” said Dawn Lissy, president and co-founder.

    For those interested, Empirical is offering two education workshop sessions Friday, Aug. 3 covering the FDA’s new expectations for biocompatibility and testing of 3D printed materials. Friday will wrap up with a tour of the test lab and manufacturing facilities along with a ribbon cutting ceremony to commemorate the 20 years of service. Saturday, Aug. 4 is the pig roast and barbecue at the Western Museum of Mining and Industry. On Sunday, groups will embark on fun activities in the Pikes Peak region, such as hiking and beer tasting.

    When Empirical Testing Corp. launched in 1998, its two employees – newly married Dawn and Chris Lissy – worked on a single test from a garage. They moved to Colorado Springs in 2004 to accommodate the company’s expanding clientele. It now employs 33 team members   supporting 38 test frames and 10 CNC machines. Ten years after founding ETC, the Lissys launched Empirical Machine to meet the prototyping and precision manufacturing needs of their clients. Five years after that, Empirical Consulting was formed to address regulatory and quality concerns for that ever-growing client base of medical device developers.

    “This has been such an amazing journey for us,” Lissy said. “We’ve come so far thanks to an amazing team of experts and clients who appreciate our dedication to ensuring their satisfaction and ultimately, patient health.”

    For more information, visit www.empiricaltech.com.