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BSI QUALITY MANAGEMENT SYSTEM – ISO 13485:2016 – MDSAP

BSI QUALITY MANAGEMENT SYSTEM – ISO 13485:2016 – MDSAP

Product catalog summary
Certificate Overview: This document certifies that Panthera Dental Inc., located at 9105 rue John-Simons, Québec, Canada, holds a Quality Management System certificate conforming to ISO 13485:2016 standards.
Certificate Details:
  • Certificate No: MDSAP 689367
  • Facility ID Number: F000357
  • Original Registration Date: November 29, 2018
  • Effective Date: May 23, 2024
  • Expiry Date: May 22, 2027
Scope of Certification: The certification covers 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.
Country-Specific Requirements:
  • Australia: Complies with Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excluding Part 1.6) - Full Quality Assurance Procedure.
  • Canada: Complies with Medical Devices Regulations - Part 1 - SOR 98/282.
  • USA: Complies with 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 - Subparts A to D.
Certification Authority: The certificate is issued by BSI, represented by Graeme Tunbridge, Senior Vice President Medical Devices. The certificate remains the property of BSI and can be authenticated online.
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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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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.