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88 document(s) found.

Minhang IATF 16949 MH

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pdf 408.41 KB
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Minhang IATF 16949 MH R

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pdf 394.04 KB
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Minhang ISO 14001

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pdf 1.16 MB
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Minhang ISO 9001

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pdf 864.17 KB
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Minhang OHSAS 18001

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pdf 1.06 MB
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Neuhas ISO 13485

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pdf 457.3 KB
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Neuhas ISO 50001

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pdf 408.87 KB
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Neuhas ISO TS 16949

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pdf 724.47 KB
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Neuss ISO 9001 DE

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pdf 703.29 KB
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Neuss ISO 9001 EN

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pdf 699.01 KB
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Pebax® Tubing for Medical Applications Datasheet

Medical-grade Pebax® tubing offers a wide range of durometers to meet the requirements of minimally invasive medical applications.
pdf 1.73 MB
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Plymouth ISO 9001

Plymouth ISO 9001
pdf 105.52 KB
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Poestenkill ISO 14001

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pdf 102.29 KB
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Poestenkill ISO 45001

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pdf 156.19 KB
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Poestenkill ISO 9001

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pdf 119.05 KB
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Portage ISO 13485

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pdf 308.74 KB
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Portage ISO 14001

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pdf 197.57 KB
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Process Validation Datasheet

Saint-Gobain’s process validation package is all-encompassing from process creation to first article inspections through final process qualification.
pdf 472.51 KB
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Rapid Prototyping Datasheet

Saint-Gobain's Rapid Prototyping program can get new medical devices to market faster.
pdf 475.9 KB
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Saint-Gobain Fluid Systems Change Notice and Communication Policy

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pdf 417.12 KB
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About Saint-Gobain

Saint-Gobain designs, manufactures and distributes materials and solutions which are key ingredients in the wellbeing of each of us and the future of all. They can be found everywhere in our living places and our daily life: in buildings, transportation, infrastructure and in so many industrial applications.

 

Saint-Gobain Performance Plastics' group of businesses gather solutions to save energy, provide protection, improve comfort and sustain the environment for a variety of markets.

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Saint-Gobain’s medical products are distributed exclusively to medical device manufacturers for use in the manufacture, assembly or distribution of their medical devices. Saint-Gobain cannot authorize the sale of its medical products directly to device user facilities (e.g. hospitals, surgery centers, nursing home, clinics, etc.), nor directly to end users (e.g. patients, patients’ caregiver, prescribing physician, nurse, pharmacist, etc.), including distributors serving device user facilities and end users directly. In accordance with every jurisdiction globally, Saint-Gobain’s customers are responsible for determining that any medical device they manufacture and market that incorporates a Saint-Gobain’s medical product, is compliant with each country-specific medical device regulations and has received proper country-specific clearance, certification or registration authorizing the sale of this medical device.


Saint-Gobain’s medical products offer covers:
- Medical Components [21 CFR 820.3(c)], intended for processing or use in the manufacture or assembly of medical devices before the finished medical device is packaged/labeled; Medical Components are intended to be included as part of the finished, packaged, and labeled device [21CFR820.3(c)].
- Finished Devices [21CFR820.3(l)] made on behalf of medical device manufacturers [21 CFR 807.20(a)(2)] under contract-manufacturing agreement. In accordance with the United States’ jurisdiction, Saint-Gobain complies with the FDA’s requirements for contract manufacturers of finished devices.

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