Quality and certifications
Quality and Certifications
From design through delivery, our quality assurance processes utilize ISO-9001 and ISO-13485 certified systems. As an FDA-registered contract manufacturer adhering to Good Manufacturing Practices (GMP), we also follow the Administration’s Quality Systems Regulations (QSR).
During manufacturing of your device components and assemblies, our process control systems monitor all key process variables, incorporating real-time statistical control (SPC) to help ensure part consistency.
Our quality policy
Donatelle is committed to meeting our customers’ expectations by providing the highest achievable quality of products and service through continual improvement and maintaining effectiveness at all levels of our Quality Management System.
More about us
Our suite of integrated contract manufacturing services, enhanced by our SmartStack® and NeuroStack® technologies, provides a competitive advantage with customizable linear contact systems. Plus, our facility features controlled environments, ISO 7 (class 10,000) cleanrooms and cleanroom production cells with integrated vision systems capable of operating at ISO 5 (class 100) level. *Moldflow® is a registered trademark of Autodesk® Inc.