OUR EXPERIENCED QUALITY AND MANUFACTURING engineers are involved in all stages of your products lifecycle and make recommendations on tools and design modifications to improve product manufacturability.
We utilize innovative, advanced technologies and processes which lead to sustainable, incremental gains through every stage of your products development.
High Quality Product
Our engineering team continually employs process analysis and improvement tools to drive product enhancements. We test for reliability and performance to your specifications as well as compliance with identified regulatory requirements. We are dedicated to meeting your requirements of producing products of the highest quality that are safe and effective.
Product inspection and testing is a focus of our quality engineering team including:
- Lot release testing and inspections
- Sterilization and biologics release
- Compliant and failure analysis
- Reliability planning and testing
- Lab testing for analysis and compliance
To ensure that good quality assurance practices are used, early involvement of quality engineering is critical to ensure that quality is maintained and built into your product. Our quality team oversees all efforts for compliance to your manufacturing specifications. We understand that safety and effectiveness are critical to the success of your medical device; therefore, we use risk-based decisions and validations to optimize your validation program and ultimately, reduce costs.
- Process validations (IQ, OQ, PQ)
- Test method validation
- Software validation
- Gage R&R