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ISO 13485

Product catalog summary

Certificate Overview:

This document certifies that Precipart Corporation, located at 90 Finn Court, Farmingdale, NY, USA, has implemented and maintains a Quality Management System. The certification is issued by DQS Inc. and is valid until November 2, 2026. The certification confirms compliance with ISO 13485:2016 standards, which are specific to the medical device industry.

Scope of Certification:

The certification covers the provision of design and contract manufacturing services for both implantable and non-implantable, sterile and non-sterile high precision metal and non-metal components and assemblies. This includes surgical instruments for the medical device industry.

Certification Details:

Certificate Registration No.: 10001444 MP2016
Date of Original Certification: November 30, 2011
Date of Revision: October 11, 2024
Date of Certification: October 4, 2023
Valid Until: November 2, 2026

Annex Details:

The annex lists various locations of Precipart Corporation in Farmingdale, NY, each with specific operational scopes:

90 Finn Court: Machining, Passivation, De-Burring
170 Finn Court: Machining, Planning, Contract Review
150 Finn Court: Machining, Gear Cutting, Shipping, QC
120 Finn Court: Main Office/HQ, Machining, Assembly
100 Finn Court: Machining, Shipping, QC, Grinding

This annex is valid only in connection with the main certificate.

Catalog excerpts

CERTIFICATE This is to certify that Precipart Corporation 90 Finn Court Farmingdale, NY 11735 United States of America with the organizational units/sites as listed in the annex has implemented and maintains a Quality Management System. The provision of design and contract manufacturing services for implantable and non-implantable, sterile and non-sterile high precision metal and non-metal components and assemblies, including surgical instruments for the medical device industry. Through an audit, documented in a report, it was verified that the management system fulfills the requirements of the following standard: Date of original certification Valid until David Tellez Managing Director Accredited Body: DQS Inc., 1500 McConnor Parkway, Suite 400, Schaumburg, IL 60173 USA The validity of the certification can only be verified by the QR-code.

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Annex to certificate Registration No. 10001444 MP2016 Precipart Corporation 90 Finn Court Farmingdale, NY 11735 United States of America Location 10001444 Precipart Corporation 90 Finn Court Farmingdale, NY 11735 United States of America 10017375 Precipart Corporation 170 Finn Court Farmingdale, NY 11735 United States of America 10017377 Precipart Corporation 150 Finn Court Farmingdale, NY 11735 United States of America 10017378 Precipart Corporation 120 Finn Court Farmingdale, NY 11735 United States of America 10017384 Precipart Corporation 100 Finn Court Farmingdale, NY 11735 United States...

Open the catalog to page 2

ISO 13485

ISO 13485

Catalog excerpts

All Precipart catalogs and technical brochures