Able Medical Devices Receives ISO 13485 Certification

Able Medical Devices, a leader in medical device development and manufacturing, has received ISO 13485:2016 certification from Ente Certificazione Macchine Srl. (ECM). ISO 13485:2016 is an internationally recognized standard that specifies quality management system requirements for medical devices.
 
“ISO 13485 certification reflects our commitment to holding the highest standards. We achieved certification very quickly due to our experienced team. Able Medical earns our customer’s trust every day and expects to be their most reliable partner. This milestone is another step that allows us to accomplish that goal.” said Eric Baldwin, vice president and general manager for Able.
 
David Surber, sales director for ECM, stated, “ECM’s Express Certification process was developed just for manufacturers like Able Medical Devices, which have quality system expertise and a short target timeline for gaining certification. Certifications don’t happen this fast without a highly competent and cooperative client. Able Medical’s commitment to quality was apparent throughout the process.”
 
Able Medical Devices, a Longyear Company, located in Michigan’s Upper Peninsula, is a partner in medical device manufacturing and development. Able Medical’s facility is fully equipped with technology supporting product development, prototypes, and contract manufacturing.

ECM is a Notified Body (#1282) and an accredited ISO 13485 Certification Body supporting European market access for medical devices and other products. Through offices, laboratories and an extensive partner network in Asia, North America, Europe, and the Middle East, ECM delivers reliable, efficient and responsive services.