ISO 13485-based outsourced 
capital equipment assembly

As part of our commitment to safety and durability, GMI Solutions’ 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. GMI Solutions is fully ISO 13485:2016 certified, and is continually improving its development and production processes.

GMI Solutions’ systems include, in part:

• ISO 13485 certification for North America and China (Chinese version).
• Management of certifications and audits by UL, CE, ETL, China CCC and many others.
• Hazmat shipping certifications for shipment of batteries or other restricted materials.
• Device Master Record retention (and healthcare DHR).
• Full ECR/ECN process.
• CAR (Corrective / Preventative Action) program.
• Continuous improvement programs.
• Fully accessible quality reporting.

As an ISO 13485 facility, GMI Solutions 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.

Improvement efforts and services have the following additional benefits:

• Supplier reduction
• Increased efficiencies
• Shorter lead times
• Improved flexibility
• Manufacturability engineering
• Ongoing value engineering and product enhancements

GMI Solutions 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. And our engineering and design services are all developed to be best-in-class.

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