Specialized Medical Devices is the single source solution that can take your project from blueprint to market-ready. Our uncompromising high standards, customer-focused services, and industry-leading materials and manufacturing know-how enable us to solve some of the toughest engineering and production challenges, and shorten the development cycle.
While Specialized Medical Devices does not design product currently, we have an engineering team ready to collaborate with your R&D and Operations Departments to accelerate your product to market. Many clients use us as a trusted resource for advice on product design, material selection, manufacturability, and product finishing.
Specialized Medical Devices’ prototyping resources help you save time, trouble, and money by proving your design concepts. We will work closely with you to create a commercial-grade prototype for testing. If necessary, we will help solve design problems quickly and assess the manufacturability of the design concept.
Evaluation of product performance is quickly completed in our world-class, on-site lab. Specialized Medical Devices’ experienced test personnel provide a full suite of testing services to ensure your product will be safe, effective, and ready to succeed in the market.
Specialized Medical Devices is unique in that we are small enough to be very responsive, yet have the resources to provide the necessary scale to manage high volume production. We pay particular attention to meeting tight tolerances (within +/- .0001"), minimizing material waste, and preserving traceability.
Our well-trained and experience personnel build everything to your exact requirements and specifications in our complete and in-house manufacturing facility, which offers:
Quality is job one at Specialized Medical Devices. Our Quality Control Department supervises every phase of every job. They oversee the initial drawings, examine early test samples for compliance to your specifications, and keep a watchful eye as your project moves through the production cycle.
Specialized Medical Devices uses a product realization-based, quality management system certified to ISO 13485: 2003, Directive 93/42 EEC. The business maintains compliance with the FDA, CGMP/QSR with capabilities for AQL sampling, and a Statistical Process Control (SPC) program.