We offer end-to-end Verification & Validation (V&V) services tailored specifically for single-use medical devices. Our expertise ensures that each product meets regulatory, performance, and safety requirements, while maintaining a strong focus on cost-efficiency and scalability.
All V&V activities are conducted in alignment with international standards such as ISO 13485, ISO 14971, ISO 11607, and IEC 62366, and are fully integrated into your design control and risk management process.
Our V&V Capabilities for Single-Use Devices Include:
- Design Verification
- Functional and dimensional testing of molded or assembled components
- Material compatibility and extractables/leachables assessments
- Seal strength and package integrity (per ISO 11607)
- Transportation and drop testing for sterile barrier systems
- Biocompatibility testing (ISO 10993 series)
- Process Validation
- IQ/OQ/PQ of critical processes: injection molding, assembly, bonding, welding, pouch fabrication
- Cleanroom qualification and environmental monitoring
- Validation of sterilization methods (EtO, Gamma, Beta)
- Traceability and batch release documentation
- Design Validation
- Simulated use and functional testing under worst-case conditions
- Usability evaluations in line with IEC 62366 for intuitive, error-free use
- Shelf-life and real-time/accelerated aging studies
- Support for clinical performance evaluation where required
- Documentation & Regulatory Support
- V&V protocols and reports ready for inclusion in technical files
- Complete traceability from user needs to test evidence
- Input for CE Marking, FDA 510(k), and other global submissions
Our goal is to help you bring safe, effective, and compliant disposable medical devices to market, on time and with confidence. Whether you are in early development or preparing for industrialization, Circum Medtech Pharma supports your project with proven V&V methodologies tailored to single-use device challenges.