MRIDA focusing on the implantable medical devices testing segment and using sophisticated surgical interventional facility / equipment broadly supports the following.
MRIDA offers a complete battery of biocompatibility studies for all classes of medical devices (ISO 10993, ISO 7405, ISO 11979) and preclinical services for performance & safety evaluation of medical devices and therapeutics (ISO 25539-2:2012 and 21 CFR 58) in the following segments.
MRIDA Core Lab uses in-house latest data processing systems which accept digital data in standard DICOM format for QCA and QVA using our test facility angiography suite or specific formats such as 3D Echo cardiography, Optical Coherence Tomography (OCT), Intravenous Ultrasonography (IVUS) etc.
Clinical evaluation is the assessment and analysis of clinical data pertaining to a particular medical device to verify its clinical safety and performance. The clinical evaluation is based on comprehensive analysis of pre-and post-market clinical data relevant to the intended use of the Medical Device.