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TPCL ISO 13485 , Medical Devices Certificate

TPCL ISO 13485 , Medical Devices Certificate

Product catalog summary
Certificate Overview:
This document is a Management System Certificate issued by DNV Product Assurance AS, certifying that Trushape Precision Castings Private Limited has a quality management system that conforms to the ISO 13485:2016/NS-EN ISO 13485:2016 standard.

Certification Details:
  • Certificate Number: 10000317569-MSC-NA-IND Rev.0.0
  • Initial Certification Date: 19 May 2021
  • Validity: Until 18 May 2024

Scope of Certification:
The certification covers the manufacture and sales of non-sterile prosthetic and orthotic components, as well as metal components for artificial/prosthetic limbs.

Issuer Information:
  • Issuing Office: DNV Product Assurance AS, Veritasveien 3, 1363 Høvik, Norway
  • Contact: Tel +47 67 57 88 00, www.dnv.com
  • Technical Reviewer: Eugenie Winger Husebye

Important Notice:
The certificate is subject to terms and conditions as outlined in the Certification Agreement. Non-compliance may invalidate the certificate.
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Catalog excerpts

TPCL ISO 13485 , Medical Devices Certificate-1

Management System Certificate Certificate No.: 10000317569-MSC-NA-IND Rev.0.0 Initial Certification Date: 19 May 2021 This is to certify that the quality system of: Trushape Precision Castings Private Limited Survey # 160, Bhavnagar – Rajkot Road, Village: Shampara, Dist: Bhavnagar – 364060, Gujarat State, India has been found to conform to the Quality Management System standard: This certificate is valid for the following scope: Manufacture and Sales of Non-sterile Prosthetic & Orthotic Components, Metal Components for Artificial / Prosthetic Limbs. Place and date: Høvik, 19 May 2021 For the issuing office: DNV Product Assurance AS Check Validity Eugenie Winger Husebye Technical Reviewer Notice: The Certificate is subject to terms and conditions as set out in the Certification Agreement. Failure to comply may render this Certificate invalid. Accredited Body: DNV Product Assurance AS, Veritasveien 3, 1363 Høvik, Norway, Tel +47 67 57 88 00, www.dnv.com

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