Concert Medical has built up an extensive suite of manufacturing capabilities required to manufacture even the most complex of Interventional Guidewires. This suite of capabilities coupled with additional value-added services such as Supply Chain and Regulatory ownership allows Concert Medical to provide strategic outsourcing solutions to our customers to you achieve their business goals such as cost reduction, volume ramp up or process efficiencies.

 

Manufacturing Capabilities

  • Assemblies & Finished Devices
  • Coil Winding
  • Profile Grinding
  • Stamping
  • Stylets and Custom Cores
  • Thermal Processing
  • Fixture & Tooling Creation
  • Rapid Prototyping
  • Metallurgical and Adhesive Bonding
  • Laser Welding
  • Lubricious Coatings
  • Custom Packaging & Labelling
  • Shipping to Sterilization (EO)
  • Continuous Improvement

Component Expertise

  • Sub-assemblies
  • Ground core wires
  • Coils
  • Hypotube assemblies
  • Soldered / bonded assemblies
  • Packaging
  • Coatings
  • Markings & Indicators
  • Tip shaping
  • Fiber Integration

Packaging

  • Guidewires can be supplied in the following formats:
    • Bulk Non Sterile (BNS) not in hoops
    • Bulk Non Sterile (BNS) in hoops, double bagged for cleanroom entry
    • Single packed sterile, and labelled
  • The sterile packaging configuration is available in 1 or 5 pouched wires per carton
  • Multiple color options for labeling and cartons

Regulatory & Design Control

  • 510(k) & CE Mark applications
  • Design History File compilation
  • Device Master Record management
  • Technical dossiers
  • Clinical complaint management and failure analysis
  • Established and tested design control process

QA & Validation Engineering

Full design assurance lab with validated test protocols and equipment

  • FDA & ISO compliant test methods
  • Risk Management
  • Bench test development
  • Biocompatibility
  • Sterilization
  • Distribution
  • Relationships with outside labs for pre-clinical testing
  • QA Test lab equipped with validated, clinically relevant test methods