Process Validation
DG Medical employs quality systems, management principles, resources, production processes and measurement techniques that allow it to consistently meet the regulatory requirements applicable to medical devices and related services. We utilize strict process validation and controls to provide traceability throughout and the highest production quality possible.
DG Medical has invested in tools and developed processes with one goal in mind: to provide products that comply with the medical industry's standards while offering the flexibility to meet customer delivery demands. Sophisticated enterprise resource planning (ERP) software allows careful planning of materials and manufacturing resources. Control systems, including statistical process control (SPC), ensure dimensional and functional integrity of every part.
DG Medical is FDA Registered and holds quality certifications in ISO 9001:2008 and ISO 13485:2003 further emphasizing our commitment to manufacturing and testing procedures that adhere to medical industry regulations.
- FDA Registered
- ISO 13485:2003 certified
- ISO 9001:2008 certified
- ERP planning and control systems
- Process documentation
