ISO Class 7 & 8 Cleanroom Manufacturing

CRI Medical Devices is ISO 13485 Certified and FDA Registered.  We specialize in the following markets: Cardiovascular, Radiology, Neurology, Gastroenterology, Urology, Orthopedics, Biopsy, Fertility, Gynecology, Obstetrics, General Hospital and Ear, Nose & Throat. Contact us here to request a quote.

Manufacturability is a key consideration from concept stage through final packaging and distribution. When it comes to contract manufacturing, we utilize our 30 years of medical device expertise to deliver on time and per specification.

PRODUCTION AND MANUFACTURING CAPABILITIES 

GENERAL

  • Heat forming
  • Pad printing
  • Plasma Treatment
  • Corona Treatment
  • Laser etching/marking/ablation
  • Tipping
  • Swaging/crimping
  • Hole punching/skiving
  • Sterile packaging and labeling
  • (Form, Fill & Seal)
  • Braided and coiled shafts
  • Dip coating
  • High-volume assembly
 
WELDING, BONDING, AND MOLDING
  • Ultrasonic welding
  • RF welding
  • Thermal welding
  • Balloon bonding
  • Adhesive bonding
  • Balloon blow molding
  • UV and solvent bonding
  • Insert molding
 
EXTRUSION
  • Single lumen high-volume and multi-lumen
  • Coiled tubing, metal reinforced, paratubing, taper extrusion, polymer extruded shafts
  • In-line printing
  • Non-Phthalate PVC material options
 
IN-PROCESS PRECISION MEASUREMENT AND CONTROL SYSTEM
  • ID/OD, wall thickness, concentricity, roundness
 
HIGH SPEED PULLER/CUTTER SYSTEM
  • Up to 1.0 dia, variable lengths
  • LCD touch screen control with operator
  • interface
  • Air pressure controller
  • Vacuum resin loading system
  • Statistical process control (SPC)
  • Precision tolerances
 
CUSTOM BALLOONS
  • Balloon bonding
  • Balloon molding
  • Proprietary forming technology
 
BRAIDED SHAFTS
  • Hydrophilic coating
  • Necking
  • Markerband swaging
  • Adhesive bonding
  • Nitinol forming
  • Laminated tapered shafts
  • Heated reflow of assemblies
  • Braid on-core
  • Stent fabrication
 
CLEAN ROOM MANUFACTURING AND ASSEMBLY
ISO Class 8 Clean Room Facilities
ISO Class 7 Clean Room Facilities
*CRI Indianapolis recently changed its cleanroom to an ISO class 7