As an industry leader dedicated to revitalizing US manufacturing, Elite thoroughly vets all suppliers to ensure that our primary materials come from the US supply chain. Unlike many overseas companies that copy OEM parts, Elite utilizes a reverse-engineering process, allowing our product development engineers to research, evaluate, and generate innovative design solutions for biomedical replacement components. This reverse-engineering process involves extensive testing of resins and other materials. Elite selects high-durability materials for all products. Often, these outperform the material used in the original part.
Elite is an ISO 13485:2016 -certified, FDA-registered, US manufacturer. We employ a robust quality management system that guarantees the safety and functionality of our product designs. Our state-of-the-art injection molding technology, quality assurance protocols, and skilled manufacturing staff ensure high-caliber products throughout the market production. Our parts consistently outperform other 3rd-party suppliers in withstanding cleaning solutions, form, fit, functional performance, and component lifespan.
As a domestic manufacturer, we offer a level of transparency to our business partners that is virtually unheard of in the 3rd-party medical device sector. Elite customers can always reach a representative on the phone; we provide onsite QMS demos, perform production audits, and encourage partners to conduct their own quality audits.
- Produce multiple prototypes to compare
- Aid in material selection to help meet your product requirements:
- Custom colors
- Additives (e.g. flame retardant, glass fiber)
- Perform full design for manufacturing review
- A dedicated team assigned to your project
- Control inventory par levels
- Improve equipment uptime
- USA based - ensuring quick turnaround
- Life cycle cost assessment
- Cavity quantity and cost comparison
- Reduce overall time to market with an iterative product development cycle
- Complete risk mitigation based on requirements
- Develop a custom quality strategy to implement
- Regulatory compliance
- Validation testing
- Testing of the form and fit of components
- Perform functional tests with prototypes
ISO certified (click here to see)