mp2016 10008415 mp2016 en - c&j industries

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Accredited Body: DQS Inc., 1500 McConnor Parkway, Suite 400, Schaumburg, IL 60173 USA 1 / 2 CERTIFICATE This is to certify that C&J Industries Inc. 760 Water Street Meadville, PA 16335 United States of America with the organizational units/sites as listed in the annex has implemented and maintains a Quality Management System. Scope: The Provision of Design Services and The Contract Manufacture of Non-Active, Non- Implantable, Sterile/Non-Sterile, Disposable/Non-Disposable Medical Devices with Measuring Function, Manual Surgical Instruments and Non-Active, Sterile/Non-Sterile, Implantable, Orthopedic Devices and Associated Metal Fabricated, Electronic and Plastic Molded Medical Components and Sub-Assemblies. Through an audit, documented in a report, it was verified that the management system fulfills the requirements of the following standard: ISO 13485 : 2016 Certificate registration no. Date of original certification Date of revision Date of certification Valid until 10008415 MP2016 2009-12-22 2020-12-03 2020-12-07 2023-12-06 DQS Inc. Brad McGuire Managing Director

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Accredited Body: DQS Inc., 1500 McConnor Parkway, Suite 400, Schaumburg, IL 60173 USA 1 / 2

CERTIFICATE

This is to certify that

C&J Industries Inc.

760 Water Street Meadville, PA 16335 United States of America with the organizational units/sites as listed in the annex

has implemented and maintains a Quality Management System.

Scope: The Provision of Design Services and The Contract Manufacture of Non-Active, Non-Implantable, Sterile/Non-Sterile, Disposable/Non-Disposable Medical Devices with Measuring Function, Manual Surgical Instruments and Non-Active, Sterile/Non-Sterile, Implantable, Orthopedic Devices and Associated Metal Fabricated, Electronic and Plastic Molded Medical Components and Sub-Assemblies.

Through an audit, documented in a report, it was verified that the management system fulfills the requirements of the following standard:

ISO 13485 : 2016

Certificate registration no.

Date of original certification

Date of revision

Date of certification

Valid until

10008415 MP2016

2009-12-22

2020-12-03

2020-12-07

2023-12-06

DQS Inc.

Brad McGuire Managing Director

Annex to certificate Registration No. 10008415 MP2016 C&J Industries Inc.

760 Water Street Meadville, PA 16335 United States of America

This annex (edition: 2020-12-03) is only valid in connection with the above-mentioned certificate. 2 / 2

Location Scope

10018328 C&J Industries Inc. 660 Terrace St. Meadville, PA 16335 United States of America

The site at 660 Terrace St. Meadville PA, 16335 performs the following activities: Warehousing and Distribution.