Certificate of Registration
Certificate of Registration QUALITY MANAGEMENT SYSTEM - ISO 13485:2003 This is to certify that:
RTI Surgical, Inc. (Also doing business as RTI Biologics, Inc.) 11621 Research Circle Alachua Florida 32615 USA
Holds Certificate No:
FM 650892
and operates a Quality Management System which complies with the requirements of ISO 13485:2003 for the following scope: Design, development, manufacture, and distribution of allografts derived from human musculoskeletal, skin, pericardium, and ocular tissues. Storage and distribution of xenograft medical devices. Manufacture of cryopreserved vials of cell suspension. This certificate is traceable to this company's original registration certificate number US04/3678 dated May 13, 2004 and issued by SGS.
For and on behalf of BSI: Reg Blake, VP Regulatory Affairs, BSI Group America Inc. Original Registration Date: 05/05/2016
Effective Date: 05/06/2016
Expiry Date: 06/13/2016
Page: 1 of 2
This certificate remains the property of BSI and shall be returned immediately upon request. An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.com/ClientDirectory To be read in conjunction with the scope above or the attached appendix. Americas Headquarters: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA A Member of the BSI Group of Companies.
Certificate No:
FM 650892
Location
Registered Activities
RTI Surgical, Inc. (Also doing business as RTI Biologics, Inc.) 11621 Research Circle Alachua Florida 32615 USA
Design, development, manufacture, and distribution of allografts derived from human musculoskeletal, skin, pericardium, and ocular tissues. Storage and distribution of xenograft medical devices. Manufacture of cryopreserved vials of cell suspension.
RTI Surgical, Inc. (Also doing business as RTI Biologics, Inc.) 4 Pearl Court, Suite B Allendale New Jersey 07401 USA
Manufacture of cryopreserved vials of cell suspension.
Original Registration Date: 05/05/2016
Effective Date: 05/06/2016
Expiry Date: 06/13/2016 Page: 2 of 2
This certificate remains the property of BSI and shall be returned immediately upon request. An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.com/ClientDirectory To be read in conjunction with the scope above or the attached appendix. Americas Headquarters: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA A Member of the BSI Group of Companies.
RTI Surgical, Inc. (Also doing business as RTI Biologics, Inc.) 11621 Research Circle Alachua Florida 32615 USA
Holds Certificate No:
FM 650892
and operates a Quality Management System which complies with the requirements of ISO 13485:2003 for the following scope: Design, development, manufacture, and distribution of allografts derived from human musculoskeletal, skin, pericardium, and ocular tissues. Storage and distribution of xenograft medical devices. Manufacture of cryopreserved vials of cell suspension. This certificate is traceable to this company's original registration certificate number US04/3678 dated May 13, 2004 and issued by SGS.
For and on behalf of BSI: Reg Blake, VP Regulatory Affairs, BSI Group America Inc. Original Registration Date: 05/05/2016
Effective Date: 05/06/2016
Expiry Date: 06/13/2016
Page: 1 of 2
This certificate remains the property of BSI and shall be returned immediately upon request. An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.com/ClientDirectory To be read in conjunction with the scope above or the attached appendix. Americas Headquarters: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA A Member of the BSI Group of Companies.
Certificate No:
FM 650892
Location
Registered Activities
RTI Surgical, Inc. (Also doing business as RTI Biologics, Inc.) 11621 Research Circle Alachua Florida 32615 USA
Design, development, manufacture, and distribution of allografts derived from human musculoskeletal, skin, pericardium, and ocular tissues. Storage and distribution of xenograft medical devices. Manufacture of cryopreserved vials of cell suspension.
RTI Surgical, Inc. (Also doing business as RTI Biologics, Inc.) 4 Pearl Court, Suite B Allendale New Jersey 07401 USA
Manufacture of cryopreserved vials of cell suspension.
Original Registration Date: 05/05/2016
Effective Date: 05/06/2016
Expiry Date: 06/13/2016 Page: 2 of 2
This certificate remains the property of BSI and shall be returned immediately upon request. An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.com/ClientDirectory To be read in conjunction with the scope above or the attached appendix. Americas Headquarters: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA A Member of the BSI Group of Companies.
