Testing of Medical Device

CE marking is an abbreviation of french phrase which exactly mean that conforming to European requirements, once the CE Mark is affixed to any product, it indicate that the product is complying to the essential safety requirements of applicable directives.

CE marking is a product certification scheme, in product certification scheme, product testing plays a very important role, it is a decision of the manufacturer to select a suitable laboratory for testing. In AVS certification services, we help manufacturers to select the most suitable testing laboratory for their certification activity.

“CE Marking” All Medical Device has 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. In addition to Labeling India is one of the most economic destinations for testing Medical Device in world class certified Laboratories. We accept this kind of business from all over the world. More Information please write to us.

  1. Electrical Safety & Electromagnetic Safety (EN 60601-1 Series – Third Edition)
    The third edition of EN 60601-1 represents a major standard in the family of EN 60601 medical electrical equipment safety standards. First publication, EN 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.

  2. Software Validation
    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 EN/EN 62304 (2006), Medical Device Software-Software Life Cycle Processes, ISO/IEC 90003 (2004) and EN 60601 series.

  3. Biocompatibility
    Used for testing of products that comes in direct contact with the human body. 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. The test consists of in vitro and in vivo conduct testing of the medical devices

    Normally these tests will be conducted by accredited laboratories, we will suggest you the most suitable laboratory for these tests the applicable biocompatibility tests can be identified by going through the standard ISO 10993-1, which is based on nature of body contact and duration of body contact

  4. Validation of Sterilization Process
    These tests are designed to verify that the product is microbe and virus-free. These tests also assure that the product's shelf-life is not compromised by its packaging.
    Validation of Sterilization process can be done In-house and also you can source from independent laboratory, we can get you the most suitable laboratory for doing the validation of sterilisation process with the help of the latest standards which are harmonised by different competent authorities and notified bodies.

  5. Labeling
    labelling play a very important role in reducing the legal ability of your product, when all necessary information present on your label along with the symbols which state it, correct labelling is a requirement of different products certification schemes as well, in CE marking of medical devices, the Harmonized standard followed is EN 980
    Regulatory Authorities require and specify information that manufacturers are expected to incorporate on the labeling when the device is placed into the market. Labeling is a written, printed or graphic matter, affixed to a medical device or any of its containers or wrappers, or accompanying a medical device, related to identification, technical description, and use of the medical device, but excluding shipping.
    These can be identified and drafted with the help of a experienced consultant. If you send us your existing label copy, our experts can identify the gap between the requirements and your existing label.

Contact us

A1-101, Ankur,
Near Cipla Foundation,
Warje, Pune- 411058

E mail :- info@avscertification.com
Telephone :- +91 - 9881946595


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