At DeSia, we support medical device manufacturers in planning and executing validation activities required to demonstrate process consistency and product quality. Our services align with international standards and regulatory expectations to ensure reliable performance throughout the product lifecycle.
Our Approach Includes:
- Defining critical processes requiring validation
- Preparing risk-based, product-specific validation protocols
- Supporting test method selection and test facility coordination
- Managing test execution and result documentation
- Compiling final reports with traceable, objective evidence of conformity
We provide validation services for:
- Packaging processes
- Cleaning processes (in manufacturing or clinical use)
- Sterilization processes (Gamma, Ethylene Oxide, Steam)
- Production processes (e.g., injection molding, extrusion, filling etc)
- Software validation (in accordance with IEC 62304, ISO/TR 80002 series)
Each validation is customized based on process complexity, regulatory requirements, and intended use of the device. We also offer guidance on worst-case condition analysis and statistical justification of sample sizes.
Do you need support with your validation process? Book your complimentary initial consultation.
