Orthopedic · Medical Device · Defense · Industrial
Machining, assembly, inspection, and documentation under one roof, by the same team. From 25-unit specialized runs through 10,000-unit production batches.
Our Quality Management System is fully audited and documented. Every component traceable from raw material through finished part. Inspection on CMM and Vision systems. Full first-article reports. Documentation to your regulatory standards.
Every step performed in our shop, by the same team. No hand-offs.
From parts to finished, audit-ready assemblies. One team accountable end-to-end.
From parts to finished, audit-ready assemblies. One team accountable end-to-end.
Flexible volumes for all programs. From 25-unit specialized runs through 10,000-unit production batches. Consistent quality and attention at every scale.
Stainless Steel
Titanium
Aluminum
Nylon and special plastics
Carbon Fiber
Cobalt chrome
Implant components, instrumentation, and complex assemblies. Full lifecycle from prototype through production. Spine, Trauma, Orthopedics, and General procedures.
ISO 13485 certified production with documentation for FDA submissions. Clean material handling and sterilization-ready protocols.
ITAR-registered manufacturing for dual-use components and specialized industrial applications. Controlled materials handling.
We work to your specifications, with full traceability and documentation, in a quality-managed environment audited against ISO 13485, FDA, GMP, and ITAR standards. Based in New Bedford, Massachusetts. The team you meet today is the team you'll work with five years from now.
A knowledgeable customer service representative takes your order, inputs it into our ERP system, and provides a quote in a timely manner.
Once accepted, we allocate the material and produce a fully bar-coded process traveler and work instruction.
Our machinists and programmers establish a process to manufacture to stringent specifications, completely traceable and documented, on a delivery schedule that meets your needs.
“Our business was challenged with a major backorder and lead time constraint and we needed to find a reliable contract manufacturer that could deliver product on-time. The Five Star team understood our concerns during our first meeting and has proven to be an A+ supplier of medical devices for us since. Having a contract manufacturer like Five Star is the reason why our business can pivot quickly with ever-changing customer demand.”
Or reach out directly:
David Cabral, President
Office: 774.206.8711
Toll-free: 877.59.5STAR
163 Samuel Barnet Blvd,
New Bedford, MA 02745
