Utilizing accrued knowhow and state-of-the-art equipment, Medibrane’s experts ensure a highly-repeatable manufacturing process that yields high uniformity and flawless products, achieving wall thickness of only a few microns.
- Defining product design specifications
- Design risk assessment
- Design verification and validation to ensure regulatory compliance
- Material, component, or product specification and traceability management, including:
- Test method development and validation
- Testing execution and report generation
- Bench testing
- Predicate testing
- shelf life and stability studies
- Packaging and labelling qualification
- Biocompatibility
- Transit and climatic conditioning (ISTA)
- Clinical literature reviews
