Medical Device Testing
Medical devices are very critical as they have a direct impact on the lives of humans. To deliver superior and safe experiences to humans, medical device manufacturers continuously innovate the devices with State of Art technology, software, and materials. However, the benefits of improvements come with hazards and should be mitigated by taking appropriate measures. The importance of medical device testing comes in this gesture.
Medical Devices have to demonstrate safety and clinical effectiveness based on the intended purpose. Certified laboratories should perform these tests to prove that the device is safe and clinically effective both for the user and the patient.
India is one of the most economical destinations for testing globally with GLP / FDA / DEA / ISO/IEC 17025:2005 accredited Laboratories. We accept business from all over the world.
EU MDR and FDA 510k Test requirements for the below Medical Devices
- A. Testing of Medical Equipment’s functions on electrical Energy (Active Medical Device)
- B. Software Medical Device testing (considered under active Medical Device)
- C. Non-Active and Implantable Medical Device testing.
A. Active Medical Device Testing
Electrical Safety & Electromagnetic Safety (IEC 60601-1 Series – Third Edition)
The third edition of IEC 60601-1 represents a significant standard in the family of IEC 60601 medical electrical equipment safety standards. First published in 1977, IEC 60601-1 has become the ‘bible’ of electromedical 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.
B. Software Medical Device Testing
The number of medical devices which are software-operated has been rising sharply in recent years. Malfunctions of the software may be life-risking. Therefore, software validation tests have become the 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.
C. Non-Active and Implantable Medical Device Testing
The Non-Active Medical Devices generally considered are the following
- A device that, in whole or part, penetrates inside the body, either through a body orifice or through the surface of the body.
- Any natural opening in the body, the external surface of the eyeball, or any permanent artificial opening, such as a stoma.
- A device that penetrates inside the body through the body’s surface, with the aid or in the context of a surgical operation.
- Any device which is intended to be introduced into the human body or to replace an epithelial surface or the surface of the eye by a surgical intervention that is designed to remain in place after the procedure
Biocompatibility Testing for Medical Devices is done to verify that the product is not toxic and does not cause allergic reactions. These tests are based on the ISO 10993-1 harmonized standard. Selection of tests and understanding of each test is essential.