Orthopaedic Quality Systems & Certifications

The orthopaedic facilities of Greatbatch Medical work to a common Quality Manual, and we have the following certification to cover all of our facilities:


As a supplier of goods to customers that may need to deliver devices to Canada, Greatbatch Medical has the following certification:


Greatbatch Medical has an approved full Quality Assurance System to enable us to act as a Legal Manufacturer of specific families of products. This certification covers reamers, intramedullary reamers and reamer handles -- couplings (external power), and osteosynthesis screws and plates -- drills:


Greatbatch Medical has the following certification for products that have a measuring function:


The Greatbatch Medical Orthopaedic facilities are registered with the US FDA. You can obtain more information at the following link:


Specific Greatbatch Medical facilities hold other certifications and have hosted other country specific audits. Please contact us if you have any questions.

Customer Service

Europe & Asia

Fernando Silva de Sousa

Tel: +41 32 358 01 11
Fax: +41 32 358 01 00
orthopaedicseurope@greatbatchmedical.com

North America

Tina Kimmel

Tel: +1 260-248-5402
Fax: +1 260-244-6308
orthopaedicsna@greatbatchmedical.com