What's New
12.23.11
Several Granite products will be showcased at the MD&M West show in February, including a turnkey medical cart, medical compute solutions, and complete turnkey medical products. Medical OEM associates are encouraged to chat with us about their electro-medical needs and how Granite can help get their medical products to market faster.
12.04.11
Granite MEDSystems is a trusted global ISO 13485 certified manufacturer. Our Shanghai, China facility has passed yet another major medical OEM audit with flying colors, giving medical OEMs everywhere further assurance that Granite products can be trusted globally.
08.01.11
Granite is pleased to announce the completion of its North American facility expansion. We'll need it, too, with the growth we've been experiencing with our medical OEM partners.
06.13.11
Granite once again participated in the MD&M show in New York. The MD&M East show was June 7th-9th, 2011, and Granite showcased several new product designs.
04.20.11
Granite participated in the China International Medicinal Equipment Fair (CMEF), which was April 16th-19th in Shenzen, China. CMEF is the largest exhibition of medical equipment, related products and services in the Asia-Pacific region. We displayed sample products and discussed programs with global medical OEMs at the show.
03.17.11
Like everyone, we at Granite are deeply saddened to see the destruction and loss of life in Japan over the last days. Everyone here extends our condolences to the Japanese people and all hope for a swift and successful recovery.
Fully Committed to Quality and Conformance. Globally.
As part of our commitment to safety and durability, Granite products conform to standard UL and CUL safety requirements as requested. Testing is performed to ensure that appropriate products comply with relevant European Union directives and include CE marking, accordingly. Our commitment to quality extends to the development process itself. Granite is fully ISO 9001:2008 and ISO 13485:2003 certified, and is continually improving its development and production processes.

Granite's systems include in part:
  • ISO 9001 certification (North America and China)
  • ISO 13485 certification (North America and China)
  • Compliant to FDA 21 CFR Quality System Regulation (QSRs) 21 CFR 820
  • Adherence to FDA cGMP
  • Compliant to FDA 21 CFR Part 11 Electronic Records and Signatures
  • Device History Record maintenance
  • Device Master Record retention
  • Full ECR/ECN process
  • CAR (Corrective / Preventative Action) program
  • Continuous improvement programs
  • Fully accessible Quality reporting
As an ISO 13485 facility, Granite has implemented a proven continuous improvement process.  This process affects every aspect of our business, with emphasis on proven production and testing processes.  We also have experience working with our OEM partners within their programs, including six sigma.

The improvement efforts and services have the following additional benefits: 
  • Increased efficiencies
  • Shorter lead times
  • Improved flexibility
  • Manufacturability engineering
  • Ongoing value engineering and product enhancements
Granite also utilizes committees for implementation and continued overview.  These committees, made up of intra-departmental members, are designed to represent all disciplines and departments and therefore assure management level support for all aspects of the ISO certifications.
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