Full Services Capabilities

Full - Service Capabilities

From small, custom-engineered solutions, to large-scale production we have the resources to support your project regardless of scale. By condensing your supply chain to become your single source partner, it allows us to be the one-stop solution to all your projects’ needs—satisfying unique application and performance needs while maintaining tight, repeatable outcomes (Medical device)

Device Prototyping (Medical device)

With hundreds of materials and tools in stock and countless configurations readily available, we can rapidly produce prototypes to accelerate your development projects.

Early prototypes are built in our laboratory which is stocked with tubing, adhesives, and mandrels, and equipped with a wide range of equipment, including:

  • 3D printing
  • Braiding
  • Coiling
  • Vertical lamination
  • Laser cutting and bonding
  • Balloon forming and attachment
  • Nitinol fabrication and heat setting
  • RF welding
  • Ultrasonic welding
  • Swaging
  • Plasma treatment
  • Silicone LIM
  • Molding
  • Pad printing
 
 

In collaboration with fast turn-around vendors, we can quickly make and change prototypes to prove concepts early.

Design & Development

ProXCath  medical offers the full range of design, prototyping, and development services. We turn your device concept into a manufacturable design, creating a path to transfer it to initial production, and ultimately, to full-scale production.

Vertical Integration is a core strength at ProXCath Medical . From concept to production, we can handle:

  • Equipment design
  • Tool & fixture design & fabrication
  • 3D printing
  • Braiding
  • Coiling
  • Vertical lamination
  • Laser cutting & bonding
  • Balloon forming & attachment
  • Nitinol fabrication & heat setting
  • RF welding
  • Ultrasonic welding
  • Swaging
  • Plasma treatment
  • Silicone LIM
  • Molding
  • Pad printing
 
 

Our Approach

We utilize an Agile team approach for the development of products consisting of three development teams and one support team. All are under the general direction of our customers and support of our regional team leaders.  We utilize our ISO 13485 design controls and the designated teams to apply our broad experience in a controlled manner.

Design & Development

Catheter Inspections & testings

Catheter Testing

ISO 10555 Catheter Testing

Intravascular catheters are designed for tasks such as supporting delivery of medicine and implantable devices into the human body. The best way to ensure that these devices are safe, retain their quality, and perform successfully is to subject them to a series of rigorous performance and durability tests. 

Our catheter testing services are performed according to pre-approved protocols and conform with required ISO and ASTM standards. We can assist you with your testing requirements and prepare your device for regulatory submission.

ISO 10555 Part 1, 3, 4, 5, Intravascular Catheters – Sterile and Single-Use

ISO 10555 defines tests for intravascular sterile use catheters. Catheter types that can be tested according to this standard include: general intravascular catheters, angiographic catheters, central venous catheters, balloon dilatation catheters and over-needle peripheral catheters.  

 

Catheter Testing Standards

ISO 10555 1, 3, 4, 5 test requirements include:

ISO 10555-1

✔ Radio-detectability
✔ Biocompatibility (Outsourced)
✔ Surface
✔ Corrosion Resistance
✔ Peak Tensile Force
✔ Freedom from Leakage
✔ Hubs
✔ Flowrate
✔ Power Injection
✔ Side Holes
✔ Distal Tip
✔ Designation of Nominal Size

ISO 10555-3

✔ Distance Markings
✔ Lumen Markings
✔ Peak Tensile Force

ISO 10555-4

✔ Radio-detectability
✔ Designation of Nominal Size
✔ Balloon Rated Burst Pressure (RBP)
✔ Balloon Fatigue
✔ Balloon Deflation Time
✔ Balloon Diameter to Inflation Pressure

ISO 10555-5

✔Lumen Identification
✔Color Code
✔Catheter Fit
✔Needle Material
✔Needle Point
✔Needle Hub
✔Joint Strength
✔Vent Fitting
Medical device | Design & Development

ISO 10555-1 – General Catheter Testing Requirements

ISO 10555-3 – Central Venous Catheter Testing Requirements

ISO 10555-4 – Balloon Dilatation Catheter Testing Requirements

ISO 10555-5 – Over-needle Peripheral Catheter Testing Requirements

Please contact us today. Our experienced engineers look forward to working with you on your Catheter testing requirements. We can also develop and validate custom test protocols that conform with required ISO and FDA standards.

Quality & Regulatory Services

Whether you are developing a Class I, Class II, Class IIb, or Class III medical device, we proXCath medical can work with you to optimize your product for manufacturability, reliability, safety, regulatory compliance, and competitiveness.