6th Feb, 2019 – CARSON CITY, NEVADA – With some dental laboratories coming under strict regulation by the U.S. Food and Drug Administration — including the government’s Title 21 CFR 820 guidance — evo820 has successfully helped dental laboratories become FDA compliant with its simple, cost-effective solution.
“I hired evo820, because I don’t know regulatory like they do,” said Greg Harris, general manager – USA at Core3d Centres. “Tim Torbenson and his team did a great job analyzing what we do and created a truly customized Quality Management System to satisfy the FDA requirements. Now I don’t have to think about it, they have my back.”
With more than 6,000 CAD/CAM dental laboratories in the United States, a Quality Management System (QMS) could easily cost over $20,000 and take eight months to implement. But for the past two years, evo820 has made a lot of CAD/CAM dental labs FDA compliant with its proprietary solution for incorporating a QMS designed by dental professionals, who only work in dentistry, for as little as $3,995 and a small monthly support and maintenance fee.
evos820’s solution, which provides a customized QMS with cloud access to documents including Quality Manual, Standard Operating Procedures and Quality forms, continues to eliminate headaches and worry for dental companies as a result of the stricter FDA guidelines.
Once exempt from FDA oversight, some dental laboratories are now under stricter regulations because the industry has moved to a computer-based workflow (CAD/CAM) – and the FDA has classified the process as Contract Manufacturing of Class II Medical Devices
“Through working with evo820 I have been able to bring our companies into compliance with the FDA; a process that would have been very daunting alone, said Travis Gasser, owner of PDA Dental Laboratory, CTO – Cadmus Dental. “They brought a wealth of experience and expertise that extinguished all unease we had about becoming compliant.”
The benefits of a comprehensive QMS implementation and documentation accelerates corrective actions and production efficiency that benefit workflow and provides baseline metrics required to determine areas of improvement within laboratory operations, as well as process weakness and corrections to eliminate remakes and increase workflow success rates.
“As a laboratory that manufactures Class II medical devices, complying with FDA regulations is of the utmost importance to DAL,” said Susan van Kinsbergen CDT, vice president of operations at Dental Arts Laboratories, Inc. “Even with a respected Quality System like DAMAS already in place, we needed to be sure we were doing things by the book. evo820 is always quick to provide answers to our questions, helping us develop customized systems and documentation to keep us in step with FDA requirements. Having evo820 on our side has given us valuable peace of mind.
To learn more about the company and services available to dental laboratories nationwide, click here
ABOUT evo820:
Based in Carson City, Nevada, evo820 was founded by dental lab professionals to help CAD/CAM dental laboratories nationwide evolve into entities that are FDA compliant. Through the company’s innovative platform, dental labs are able to satisfy the FDA’s requirements by following a practical and affordable implementation of a customized Quality Management System.
Media Contact
Company Name: Evo820
Contact Person: Brad Rand, evo820 CEO
Email: Send Email
Phone: (844) 438-6820
Country: United States
Website: evo820.com