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Product Co-Development

Material and Product Co - Development

Today's health care industry demands innovation matched with value. Many successful companies recognize that they can't always be the experts on everything.

That's where Saint-Gobain comes in. Our teams of engineers and chemists offer extensive material and process knowledge to meet your most demanding applications and design needs for your medical device, all within your budget. Through our state-of-the-art co-development process, we'll work side by side with your team throughout the development and life cycle of your product.If we can't offer the most effective material or process, we won't hesitate to refer you to another manufacturer.

Saint-Gobain is the leader in process and product development, offering you the following services:

Tooling Design and Build
  • Rapid prototypes to reduce product development cycles
  • Recommendations for design for manufacturability
  • Advanced tool designs that reduce product costs
Material Testing and Characterization

• On-site material testing capabilities
• Advanced material characterization and analysis capabilities
• Application development laboratories for full system testing

Project Reporting System

• Tracks all facets of the design and pre-production phases
• IP/OP/QP validation protocol
• Communicates key items to design team
• Provides effective and efficient program implementation

Assembly and Test Fixtures

• Successful transition from pre-production to production
• Manufacturing and quality assurance aids
• Problem-free manufacturing

Product Development Reports

• Project management timeline
• Advanced product quality planning status report
• Risk and opportunity assessment report
• Open issue report

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.

 

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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