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BSI QUALITY MANAGEMENT SYSTEM – ISO 13485:2016 – MDSAP
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BSI QUALITY MANAGEMENT SYSTEM – ISO 13485:2016 – MDSAP

BSI QUALITY MANAGEMENT SYSTEM – ISO 13485:2016 – MDSAP
1 /1Page

Catalog excerpts

BSI QUALITY MANAGEMENT SYSTEM – ISO 13485:2016 – MDSAP-1

Certificate of Registration QUALITY MANAGEMENT SYSTEM - ISO 13485:2016 This is to certify that: Panthera Dental Inc. 9105 rue John-Simons Québec Québec G2B 0S6 Canada Facility ID Number: F000357 Holds Certificate No: The company listed on this certificate has been audited to and found to conform with ISO 13485:2016 including the following country specific requirements: Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excluding Part 1.6) - Full Quality Assurance Procedure Canada: Medical Devices Regulations - Part 1 - SOR 98/282 USA: 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 - Subparts A to D The design, development, manufacture, and distribution of orthosis for sleep disorders and components for prosthetic reconstruction devices including bars, abutments, and other associated dental instruments. For and on behalf of BSI: Graeme Tunbridge, Senior Vice President Medical Devices Original Registration Date: 2018-11-29 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.

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