Our Locations

Integer > North America > Pembroke Pines

Pembroke Pines, Florida

     Site capabilities include:

      Engineering Research & Development

• Proof-of-Concept Early Prototype Work
• On-hand inventory for quick turnaround prototypes
• Pilot capabilities including braiding, tack and laser welding
• Design/Prototype Characterization
• Physician preference evaluation for design selection
• Deep neurovascular experience to evaluate new trends
• Design for Manufacturability
• Initial Process Development
• Tooling Development via 3D printing & rapid prototyping
• Leveraging local and corporate fabricators for high volume equipment and tooling

      Engineering Product Development

• Design History File generation and maintenance
• In-House Design Verification
• Tensile, burst, leak, kink, inflation/deflation, torque, particulate testing/counting
• Simulated Use & Usability Validation Studies
• Off-the shelf and custom FDA-compliant neurovascular models
• Active agreements with physicians available for evaluation/feedback
• Full Lifecycle Project Support
• Ongoing sustaining engineering services
• Project Management
• Coordinate internal teams & streamline customer interactions

      Operations Core Competencies

• Manufacturing Process Development and scale-up
• Extensive experience in medical device Process Excellence, DFM
• In-House Molding
• In-house mold tooling design & local fabrication
• Nylon, Polycarbonate, TPU/TPE
• Catheter Assembly
• Coil winding (6ea)
• Lamination/Reflow Equipment (4ea)
• Hydrophilic Coating
• Automated coating and lubricity testing
• Packaging/ Labeling
• Process Validation
• Process Characterization
• IQ/OQ/PQ/SV

      Regulatory Support Services:

• Comprehensive Regulatory Support; Dedicated team with extensive regulatory expertise (+ 20 successful regulatory submissions within the US (FDA), Europe (CE Mark) and Asia).