Medical Devices Testing and Calibration Facility
Medical Devices Testing and Calibration Facility (MDTF) was established in 2022 under the mentorship of the Department of Medical Devices and was dedicated to the nation on 28th April 2023 by Ms. Aparna S, IAS, Hon’ble Secretary, Department of Pharmaceuticals, in the presence of Dr. USN Murty, Founder Director, NIPER-Guwahati, for serving in the field of testing and calibration of medical devices by ensuring the quality, safety, and compliance as per MDR-2017and ISO 17025:2017.
Vision
To be a department of excellence in promoting high-standard testing of medical devices through the dissemination of knowledge for the ultimate benefit of the Indian society and industry.
Mission
To carry out testing for medical devices as per international standards. – Tested once at NIPER-G, accepted globally.
To be an interdisciplinary source of professional manpower in the field of Medical Devices and associated sectors.
To support MSMEs, start-ups to get their products tested as per global standards and unlock the global markets with quality confidence.
What does MDTF do?
The facility is the first and only Govt. lab dedicated to medical device calibration in the entire Northeast.
MDTF follows ISO 17025:2017 LQMS, IEC 60601-1 for testing and calibration of medical devices as per MDR-2017, CDSCO, EUMDR and USFDA regulations.
MDTF NIPER Guwahati is the first ever NABL-accredited facility on medical devices among all the NIPERs.
- MDTF comprises two sections
- 1. Medical Electronics Calibration Section
- 2. Mechanical Testing Section
Scope and Certificate
Medical Devices Testing and Calibration Facility got NABL accreditation for twenty scopes for permanant facility and nineteen scopes for on-site calibration.
Medical Electronics Calibration Section
The NABL accreditation covers 20 different scopes related to medical electronic equipment like ECG, defibrillators, external pacemakers, Electrical safety etc. under Patient Conditioning/ Maintenance and Imaging/Plotters group.
MDTF is also NABL accredited for on-site calibration, which opens the arena to visit any hospital in the remotest part of the northeast region and perform the calibration at the hospital itself without the need for large medical equipment to be moved or transported to testing labs.
We are working further to expand its scope towards medical device testing and calibration.
Mechanical Testing Section
Mechanical section houses Universal testing machine (5kN & 250N) with various grips/fixtures suitable for mechanical testing of syringes, needles, bandages, catheters, sutures, surgical gloves and other MDs.