Quality: ISO 13485 and ISO 9001 Certified

ISO 9001-2015

ISO 13485-2016

Our Cleanroom with Certificate

Quality: ISO 13485 and ISO 9001 Certified

At GTI Medical all medical projects are complying with ISO13485 & ISO 9001 standards.

GTI Medical provides the following QA Services:

  • Certificate of compliance, Certificate of Analysis and final inspection report are provided with each shipment (COC, COA & COT).
  • High precision measurement system using Four Axis Smart Scope OGP system.
  • Tensile testing and reporting.
  • Af temperature testing.
  • In house product packaging testing (dye/peel/burst).
  • In house Clean Room monitoring capabilities.
  • Custom packaging & labeling.

Quality Assurance (QA)

Our QA team assures the highest quality of manufactured products by implementing risk management methods to avoid setbacks in the delivering process to customers.

GTI’s QA team effectively engage in promoting quality assurance by improving process development and testing methods.

At GTI Medical our quality team oversee operations to ensure compliance with regulations while maintaining production costs, allowing us to provide our clients with the highest quality standards to ensure patient safety.

Technology Transfer

At GTI Medical, we are happy to share our knowhow, which is based on more than 25 years of experience, with other companies or Institutions.
As a company known for its creative processes and unconventional solutions we do not just think outside the box, we think like there is no box.
TT project may include, upon request, a full technical data package and training of employees.
The following major technologies can be transferred:
  • Laser cutting of different types of stents (Nitinol, SS316LVM or CoCr).
  • Electro polishing processes for Nitinol, SS316, CoCr, MP35N and Titanium parts.
  • Laser welding of markers made of different materials mainly to increase radiopacity (Tantalum, Au, Pt-Ir etc.).
Projects GTI completed to date:
  • Technology transfer of Electro-polish process, including design and built of a dedicated semi automatic production line with a chemical hood for Nitinol stents and parts (for US company).
  • Design and built of low cost Af measurement device.
  • Process transfer for Laser cutting of miniature resistor parts made of 10µmm sheet metal thickness.
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Laser Markings

There has been an increase in demand for medical device manufacturers to include Unique Device Identification (UDI) in their marking process.
GTI is experienced in complying with UDI requests.
Why Laser Marking is an Effective Solution:
  • Permanence through the product life span.
  • High contrast marking.
  • Sterilization resistant.
  • Flexibility through digital digitization.
  • Hygienic and smooth.
Laser markings for medical devices and instruments provide greater accuracy in reporting and traceability while reducing medical errors by allowing health care workers to quickly identify instruments.
machine markings
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Laser Welding

GTI Medical offers precise spot and CNC seam welding for various materials including Stainless Steel, Nitinol, Tantalum, Platinum Iridium, Brass & Cobalt Chrome.
GTI’s Skillset includes:
  • Proficiency in creating complicated joins of dissimilar materials.
  • Low heat application minimizes the distortion of the product.
  • High strength welds to eliminate the need for a filler material to be used.
  • Micro spot welding for Radiopaque Marker in Tantalum, Gold and Pt/Ir.
  • Precision welding thin wire components of dissimilar materials for delivery systems.
  • Welding Electrode rings to wire leads for delivery systems & electro leads to wire leads.
  • Accuracy to weld miniature parts without damaging them.
  • In house Tensile testing and reporting of wire welded parts.
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Electropolish & other surface treatments

Experts in providing superb Electropolish treatment on Nitinol, Stainless Steel & Cobalt Chrome parts.
Four main advantages to perform EP treatment on products after laser processing are:
  • Breaks sharp edges to prevent vein & artery damage during surgeries.
  • Boosts corrosion resistance & biocompatibility of the product.
  • Improves fatigue life of medical parts.
  • Enhances product visibility (shine).
Passivation:
The benefits for this surface treatment process include:
  • Improve corrosion & rust resistance.
  • Strengthen & preserve the appearance of the metal after laser cutting.
  • Allows for higher bath temperatures and the use of ultrasonics.
  • Decrease and eliminate heavy metal ion while retaining the appearance of the part.
If you are interested in having Electropolish capabilities in your facility Click Here. 
Note: GTI Medical offers other surface treatments including deburring, micro blasting, tumbling and pickling. Contact us for additional information.
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Nintol Processing

GTI’s aptitude with Nitinol processing span over 25 years.
Our capabilities include:
  • Laser manufacturing.
  • Laser welding.
  • Electropolish and other surface treatments.
  • Shape setting.
  • In house manufacturing of mandrels and fixtures.
  • Austenite Finish temperature (Af) testing & reports.
This self-expanding material of choice for applications that require enormous flexibility and motion is a staple in the cardiovascular, neurovascular, endovascular, peripheral vascular, orthopedic, spinal, urology and dental arenas.
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Assembly

GTI can quickly and cost-effectively convert your component and sub-assembly designs into a finished medical device.
If you require simple, complex or multi-component assemblies, GTI can optimize batch sizes and economies of scale for 10 or 10,000 pieces.
Our Clean Room offers:
  • Temperature controlled environment.
  • Class 10,000 / ISO7 Clean Room complying with: GMP, FDA, CE.
  • In house Clean Room monitoring.
  • Laminar hood.
  • Complete product assembly.
  • Packaging and coordination of sterilization.
  • Sophisticated, validated sealing machine.
  • Sealing temperature, cycle time and sealing pressure controlled by predefined parameters.
  • Robust shop floor control and quality management systems are designed to support traceability.
For cost reduction and performance requirements, GTI offers a wide range of product packaging capabilities, from bulk pack to a fully kitted and assembled product, which we ship for sterilization.
Note: As a value-add service, GTI offers start-ups the option to rent our Clean Room on an hourly basis allowing clients the opportunity to work in real time with our dedicated team of engineers and QA team.
Our Cleanroom with Certificate
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Optical Dielectric Coating

GTI offers the following technologies:
  • Silver & Gold plating.
  • Fiber optic manufacturing & assembly.
  • Electronic component manufacturing & assembly.
In addition, GTI offers the capability of depositing optical dielectric coating for hollow CO2 fiber optics.
This process provides low losses, a nearly pure mode delivery and a good high laser power transmission. By proper design of the dielectric thickness, the guide can deliver a very flexible and robust waveguide, producing an optical high powered laser device used for medical devices as well as for other applications.
Fiber Optics
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Machining

GTI Medical offers our customers precision machined part to compliment the laser manufacturing & assembly process required to provide the client a complete manufacturing and Turnkey experience.
We can ensure that parts requiring machining are done with precision & skill bringing surgical tools, orthopedic implants, components and robotic assisted surgical devices to market quickly.
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Silicone Services

GTI Medical’s silicone services include silicone coating, silicone dipping & laser cut of silicone sheets.
GTI offers silicone and other polymers applications for medical components that produces a smooth, durable, and biocompatible finish.
Silicone is applied to medical devices such as stents graphs, veterinary implants, filtration devices and Hypo tubes to enhance patient comfort.
veterinary
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Bending

GTI offers bending services to accommodate multiple step parts between laser cutting and surface treatment. Keeping the part in house in our highly regulated environments maintains superior product and cost competitiveness.
perferated bend
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Machining

GTI offers precision machined parts that compliment the laser processing and assembly activity to provide a greater manufacturing and turnkey experience.
We assure that parts requiring machining are done with accuracy and skill, bringing surgical tools, orthopedic implants, components and robotic assisted surgical devices to market quickly.
machining
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3D Printing – Enhanced Productivity

3D printing has become the new standard for surgical excellence. The potential for design, engineering, customized 3D models and surgical instruments is endless.
3D printing technology enables the use of a patient specific anatomy to create a physical 3D model which can help to accurately plan a surgical approach, or alternatively, to model custom prosthetics and surgical tools.
This unique technology helps surgeons and hospitals to run an easier, more efficient and faster procedures, in addition to shortening the patient’s rehabilitation process.
All parts are produced using fully certified biocompatible materials and all instruments are being sterilized prior to use.
3D printed parts are used in the following surgical categories:
  • Orthopedics               
  • ENT
  • Orthopedics Oncology
  • Nephrology
  • Oral & Maxillofacial
  • Cardiology
  • Neurosurgery
  • Gastroenterology
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Nitinol Parts

The introduction of Nitinol with its self-expanding properties has greatly impacted the medical industry and revolutionizing the success of surgeries. Today, Nitinol is a preferred material in the medical device industry, where advanced stents, as well as a variety of other flexible instruments, are being made from it.
Nitinol has few special features and properties that makes him suitable for the medical sector:
  • Super elasticity properties for shape memory deployment.
  • Bio-compatible for orthopedic implants, expanding stents, heart valves.
  • Kink resistant.
  • Constancy of stress.
  • Dynamic interference and fatigue resistance.
  • Sustainability of very high deformations.
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Robotics

Laser cutting technologies are being used in the development of robotic assemblies. Many components in the robot can be laser cut at GTI and therefore can be custom made to meet your engineering and design specifications.
The commonly used robotic surgical system consists of a mechanical arm and a camera arm attached to surgical instruments which is controlled by a surgeon being seated at a computer console which can be operated from the same room as the surgical table, or remotely from anywhere in the world.
As a complete turnkey solution provider, GTI Medical can manufacture, weld and laser mark your robotic parts quickly and efficiently.
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Surgical Tools

We are active in building surgical instruments for Tier 1 companies such as Johnson & Johnson, Stryker and Lumenis.
Our company has taken on projects from Tier 1 suppliers to build surgical tools, helping them to reduce time to market by more than 60% (from 36 to 13 months) resulting in a per-scheduled product launch, which consequentially, provided them with a relative advantage in a highly competitive and time sensitive market.
GTI can produce single surgical tools or take responsibility and provide a turnkey solution to manufacture, assemble and package complete kits.
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Turnkey Solutions

Over the years, GTI Medical has developed the ability to take on the responsibility for entire manufacturing project and presents it to the client completely finished and ready to be used.
Such projects may include design for manufacturing, cost reduction phase, overall purchasing, technical support, writing of work instructions, assembly, final inspection, labeling, packaging and strict quality assurance.
Below is partial list of projects done by GTI:
  • Navigation system assembly.
  • ENT surgery device.
  • Precise surgical tool for enhanced robotic assisted surgery.
  • Microsurgical precision tool for ear surgery.
  • CO2 fiber optic for aesthetic surgery.
  • Variety of surgical tools & accessories.
Assembly
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Miniature Parts

GTI Medical provides rapid and responsive manufacturing of implants and miniature parts using Nitinol, Titanium and Stainless Steel. Tube size starting at OD 0.15mm, Foil thickness of 10 ųm mm and up.
The combination of our experience with an advanced nitinol implant production, makes GTI Medical the best source for producing your newest miniature implant and component designs.
Depending on the project, traditional methods are combined with additive manufacturing to provide the best solution even for the most complex design.
In this challenging and highly sophisticated sector, GTI Medical provide its customers with quality, regulatory compliance, competitive pricing and with on time delivery (lead time).
miniature-parts-assembly
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Needles

GTI Medical provides manufacturing service for unique pencil point needles with an OD of 0.4 mm (0.016 inches) and up.
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Laser Cutting Tubes and Plates

GTI delivers precision laser cutting of tubes and plates made from implantable metal alloys and polymers intended for use in surgical tools, medical components, flexible tubes, robotic parts, implants, electrical resistors and more. All applications are cut to meet your tightest tolerances and specifications.
Our processing services combine:
  • Material format: Tube • Sheet • Strip • Foil • Wire • Silicone Sheets
  • Tube cutting specification: OD: 0.15 mm to 40 mm
  • Tubing wall thickness: 5 ųm to 1.5 mm
  • Plates • Foil • Strips are cut on Fiber Laser system t=0.010mm-2.5mm
  • Raw Material: Nitinol • Implant grade Stainless Steel • SS316LVM, SS304, SS420, 17-4PH • Cobalt Chrome • Titanium, Tantalum, Zinc, Copper • Gold • Silver • Platinum Iridium • Ceramic material (ALo3) • Exotic metals and more
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