Medical Device Testing Services

medical device services

Manufacturing & Testing Service

Our medical device services start from product design & development to batch release; we specialize in productassembly, packaging, sterilization & testing. We use & apply various different techniques, machines & instruments for successful launching of your requirement with considering international harmonized standards. Also helps you to makes your idea workable for customized application.

1. Medical devices manufacturing services:

Our medical device manufacturing process services gives you complete solution for your product to be launched in market. We involved in the following segments of sourcing & implementation –

1.1 Product Assembly: 

  • Raw & semi-finished material selection & sourcing
  • Product cutting (Mechanical or  Laser Techniques)
  • Catheter tipping (Open tip type)
  • Forming (Close or Open type)
  • Hole punching (Mechanical or  High Frequency)
  • Bonding (Adhesives or Heating)
  • Welding (High Frequency & Ultrasonic)
  • Sutures swaging & crimping (Absorbable & Non-Absorbable Sutures)

1.2 Packaging: 

  • Packing material selection & sourcing
  • Medical grade pouch packaging
  • Tyvek & medical grade blister packaging,
  • Aluminum blister moisture proof packaging.

1.3 Sterilization: 

  • Ethylene oxide sterilizer installation & commissioning
  • Sterilization validation
  • Sterilizer calibration
  • Protocol & report preparation

2. Medical device testing services:

We gives solution for functional & performance testing of various range of surgical medical devices as per FDA, CE, ASTM, and ISO guidelines. Our services help in test method development, method validation, process optimization & process validation. Also provide best solution for biocompatibility testing, chemical testing, stability testing & clinical evaluation of medical devices.

We specialize in calibration & testing services for all small bore connectors specified in ISO 80369-1 to 7 & 20. We are able to help for customized testing application to makes your idea workable.

2.1 Testing for Small Bore Connectors as per ISO 80369-20:

  • Gauging test
  • Unscrewing torque
  • Separation force
  • Stress cracking
  • Resistance to overriding
  • Ease of Assembly

2.2 Testing Solution for Needles: 

  • Needle sharpness test
  • Needle penetration test
  • Needle stiffness test
  • Needle-hub bond strength test
  • Needle bending/resistance to breakage test
  • Needle tip inspection test
  • Suture needle ductility & elasticity test
  • Needle hub connectors (luer) test

2.3 Testing Solution for Syringes:

  • Syringe plunger actuation force test
  • Leakage test
  • Syringe luer test

2.4 Testing Solution for Catheters, Tubings, Bags & Bottles:  

  • Breaking force & connection fastness test
  • Leakage & burst test (air & water)
  • Flow rate test

2.5 Testing Solution for Medical Packaging:

  • Medical film & paper tear & pin hole test
  • Blister pouch peel off/seal strength test
  • Blister burst & leakage test

2.6 Chemical Tests Implementation: 

  • Acidity or Alkalinity
  • Metal Ions (barium, chromium, copper, lead, and cadmium)
  • Residue on Evaporation
  • Resistance to Corrosion
  • Ultraviolet Absorption
  • Acid Value
  • Safonification Value
  • Extractable Colour Test
  • Ethylene Oxide Residue
  • Moisture Content (Karl Fischer -Coulometric)

2.7 Biological Tests Implementation: 

  • Sterility test
  • Bacterial endotoxin test
  • Biological indicator test

2.8 Stability Study Tests Implementation:

  • Accelerated or real time ageing of sterile barrier system
  • Accelerated or real time ageing of medical devices

2.9 Surgical Medical Device Biocompatibility Tests Implementation:

  • Cytotoxicity
  • Sensitization
  • In-Vitro Biological Reactivity
  • Intracutaneous Irritation

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