Medical Device Testing

“CE Marking” All Medical Devices have to be demonstrated safe and effective. While clinical trials, and other types of testing, are aimed at demonstrating the effectiveness of the product, there is a different array of specific tests (Harmonized Standards) your product has to undergo in order to assure its safety. These tests should be performed by certified laboratories to prove that the device is safe both for the user and the patient.
In essence, the safety requirements, despite slight technical variations, are valid in all major markets - Europe, the USA and most other countries. India is one of the most economic destinations for Medical Device testing in world having  cGMP compliant, FDA established registered, DEA registered and ISO/IEC 17025:2005 accredited Laboratories. We accept this kind of business from all over the world.

We do testing for the following type of medical devices

  • Testing of Medical Equipment’s functions on electrical Energy (Active Medical Device)
  • Software Medical Device testing (considered under active Medical Device)
  • Non Active and Implantable Medical Device testing.

  • Testing of Medical Equipment’s functions on electrical Energy (Active Medical Device)
  • Electrical Safety & Electromagnetic Safety (IEC 60601-1 Series – Third Edition)
    The third edition of IEC 60601-1 represents a major standard in the family of IEC 60601 medical electrical equipment safety standards. First published in 1977, IEC 60601-1 has become the ‘bible’ of electro medical equipment safety and the parent standard of over 60 particular device standards ranging from diagnostic electrocardiographs to electron accelerators used in radiotherapy. These tests should be carried out on all active electrical products. Compliance with all these standards should be taken into account during the design process.
    Write to us for more information and test fees. Our Email ID – enquiry@i3cglobal.con 

    Download List of Harmonized Standards

  • Software Medical Device testing (considered under active Medical Device)
  •  The number of medical devices which are software-operated is rising sharply in recent years. Malfunction of the software may be life-risking. Therefore, software validation tests have become most demanding. Conformity Assessment procedures require consideration of the development lifecycle procedures for document control and configuration management and control of combinations between software versions and intended hardware. Published software medical device standards (not an exhaustive list) include IEC 62304 (2006), Medical Device Software-Software Life Cycle Processes, ISO/IEC 90003 (2004) and IEC 60601 series. 

  • Non Active and Implantable Medical Device testing

  • The non-active devices generally considered are the following

    • A device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.
    • Any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.
    • An device which penetrates inside the body through the surface of the body, with the aid or in the context of a surgical operation.
    • Any device which is intended to be totally introduced into the human body or, to replace an epithelial surface or the surface of the eye, by surgical intervention which is intended to remain in place after the procedure

    The following are the important tests to be conducted for above category of medical devices

    • Sterility Testing
    • Bio Burden Testing
    • Bacterial Endotoxin
    • Ethylene Oxide Residue Testing in accordance with ISO 10993
    • Identification and Purity Testing of Raw Materials
    • Stability Testing
    • Sealing Integrity Test for Packaging Materials
    • Toxicity Studies

    Other Tests

    • Extractable/Leachable Testing
    • Material Characterization
    • Physical Testing
    • Bioburden Testing
    • Biological Indicator Testing
    • Sterility Testing
    • Elemental Metals

    Biocompatibility
    This test is used to verify that the product is not toxic, and does not cause allergic reactions. These tests are based on the ISO 10993 standard.
    It is very important to read and understand before sending any medical device for testing.

    BIOCOMPATABLITY TESTING .. Read more>>

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