Medical Device Testing & Calibration Services - Customer Service Cell, Biomedical Technology Wing
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum
An Institute of National Importance under Govt. of India
About Testing Services
The Biomedical Technology Wing of the Institute, located at Poojapura Campus offers selected testing services to external customers - primarily intended for the medical device industry in the areas of Physico-chemical characterization as well as biological evaluation of materials. The testing services are coordinated by the Customer Service Cell (CSC), which is the point of all contact and communication for the external customers with the Institute.
The CSC will extend you with all support such as providing information on the testing services, testing timelines, limitations, test methods, test charges, payments etc. If required, interaction with testing laboratory will be facilitated by the CSC. Please feel free to contact the CSC for all your queries regarding testing services.
An Overview of the Testing Services offered:
Click here for the List of equipments available at Central Analytical Facility
1. Characterization of materials as per international standards using analytical techniques:
FT Raman Analysis FT-IR & UV-Vis spectrophotometry Thermal Analysis (DSC, TGA, DTA) HPLC and Gel Permeation Chromatograhy X-ray powder diffractometry Tensile / Compressive testing Line/surface profilometry Transmission and Scanning Electron Microscopy (TEM & SEM) Energy Dispersive X-ray analysis (SEM-EDS) Micro CT scanning
2. Preclinical Functional and Safety Evaluation of Medical Devices
Preclinical studies: Safety and functional performance evaluations in large animals are also offered as part of the testing service and the Institute possess excellent facility and expertise for the evaluation. These studies are carried out on a study mode based on a study plan/protocol which is prepared based on the requirement of the customer. Budget for the study is made and is to be paid by the sponsor. These animal studies are conducted subject to approval by the CPCSEA.
Quality Management System and Accreditation
Our Quality management system for testing services confirms to the international standard ISO/IEC 17025: "General requirements for the competence of testing and calibration laboratories".
About twenty biological tests which includes biocompatibility testing also are accredited by Le Comite Francais d'Acreditation (COFRAC) of France. The test reports of all accredited tests are issued with the COFRAC logo. Click here to view the scope of accreditation.
Calibration services (mechanical and thermal calibration) is accredited by National Accreditation Board for Testing & Calibration Laboratories (NABL).
Click here to view the scope.
Click here to view the accreditation certificate.
Physico-chemical testing (Residual EO, Compositional Analysis of materials using TGA, Determination of Transition Temperature & Enthalpies of fusion and crystallization of materials using DSC) is also accredited by National Accreditation Board for Testing & Calibration Laboratories (NABL).
Click here to view the scope.
Click here to view the accreditation certificate.