ISO 13485-based outsourced 
capital equipment assembly

As part of our commitment to safety and durability, GMI Solutions’ products conform to 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:

• FDA Certified for manufacturing finished medical products.
• 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 a proven continuous improvement process. This process affects every aspect of our business, with emphasis on proven production and testing techniques. In addition, we work within our OEM partners quality programs.

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

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