Our laboratory capabilities enable us to offer a comprehensive testing and validation package, fully aligned with medical device and pharmaceutical regulatory requirements. These services support both product development and industrial-scale manufacturing, ensuring quality, safety, and compliance at every stage.
Our laboratory services include:
- Dimensional inspections using Coordinate Measuring Machines (CMM)
- Process capability analysis (Cp, Cpk)
- Packaging validation, including seal strength and integrity (per ISO 11607)
- Mechanical testing of components and assemblies
- Bioburden testing
- Sterility testing and routine monitoring
- Bacterial endotoxin testing (LAL test)
- Particulate contamination testing
- Shelf-life and accelerated aging studies
- Biocompatibility assessments (ISO 10993)
- Transportation and drop testing for final packaging validation
These capabilities allow us to support your product through design verification, process validation, and regulatory submission, while also ensuring ongoing quality control during manufacturing.
