Co-designing
Co-designing with OEMs: Enhancing manufacturing processes to improve reliability and capabilities
Design for manufacturing
At SpiTrex Orthopedics, we work closely with our OEM partners to effectively create a better product at a lower cost. Our experienced team of design engineers uses the latest technology and a Design for Manufacturing (DFM) approach to ensure that every aspect of the design supports the customer's needs and cost efficiencies whilst maintaining the highest quality standards.
We understand the importance of regulatory compliance, which is why we offer CE Mark and FDA file support for all of our partners. We work with our partners to ensure that their products meet regulatory requirements, and we provide comprehensive documentation support to facilitate the approval process.
Verification and Validation
Our team also employs a Verification and Validation (V&V) approach to ensure that our partner's products are reliable and meet the highest standards of quality. Our state-of-the-art testing facilities and experienced team allow us to perform a wide range of tests, such as fatigue testing or chemical analysis, to ensure that our partner’s products meet all necessary regulatory requirements.
Strict Quality Control
At SpiTrex Orthopedics, we understand that the success of our partner's products relies on quality and reliability. That's why we employ strict quality control measures throughout the entire manufacturing process, from initial design to final inspection.
Co-designing Services
Our co-designing services are based on open and honest communication, and we provide regular progress updates to ensure that our partners are always informed. We're committed to working closely with our partners to optimize their manufacturing processes and enhance the reliability and capabilities of their medical devices.