Materials
Capabilities

Markets

Here is a sample of the markets we serve.  Please contact us if you do not see the market you are looking for, we can help you.

Ophthamology

Ophthalmology
Surgery

Surgery
Cardiology

Cardiology
Drug Delivery

Drug Delivery
Nephrology

Nephrology
Diabetic Care

Diabetic Care
Other Medical Markets

Other Medical Markets

Blog

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Business Continuity Planning (BCP) - Planning For... Business Continuity Planning (BCP) is: the process involved in creating a system of prevention and...

September 26th, 2019

FDA - Guidance for Industry - Process Validation:... This guidance outlines the general principles and approaches that FDA considers appropriate...

April 01st, 2019

Case Study

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Ivenix

October 10th, 2019

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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