Quality is one of the over-arching themes in all projects at Secant Medical™. We have a robust, comprehensive quality system in place for medical textile and fabric development – because in your field, quality is an absolute requirement.
Our Quality Commitment
Of course, we have a quality system certified to ISO 13485:2003. But to us, that's a basic requirement; we go above and beyond such a quality baseline for our customers. A cross-functional team of engineers – from development, manufacturing and quality disciplines – working together on each project is one way we ensure quality for every medical textile device project.
Altogether, our quality-oriented services and systems give you assurance of our commitment to your product's integrity:
- Biocompatibility assurance
- Environment, health and safety systems
- Quality monitoring
- Validation planning and execution
- Ultra-filtered, endotoxin controlled validated water systems
- Microbiological testing
- Quality planning and protocol development
- Risk analysis
- Custom test method development and validation
Visit Advanced Manufacturing for details on our manufacturing quality standards.