TÜV Rheinland, a global leader in independent technical services announced the opening of its Biomaterial and EMC (Electro Magnetic Compatibility) Testing Laboratories located at Andhra Pradesh MedTech Zone (AMTZ), Visakhapatnam, Andhra Pradesh. These newly opened laboratories, housed within the TÜV Rheinland Medical Device Centre of Excellence have been accredited in accordance with International Standard ISO/IEC 17025:2017 for Medical, Non-Medical Devices and EMC Testing Services by the National Accreditation Board for Testing and Calibration Laboratories (NABL). The EMC Testing Laboratory has also been accredited by the American Association for Laboratory Accreditation (A2LA).
This accreditation demonstrates TÜV Rheinland’s technical competence for a defined scope to serve a diverse range of product categories and the operation of a laboratory quality management system which will enable customers to gain entry into domestic and international markets.
At the Medical Device Centre of Excellence, TÜV Rheinland offers customers an extensive list of services which includes Regulatory Compliance, Product Performance, Engineering Analysis and Reliability Services for various active and non-active medical devices such as Medical Ventilators, Face mask, X-ray Systems, Infant Care Devices, Health Monitoring Devices and Medical Implants. It also offers a variety of testing services for IT and Telecom products with speciality in Electronic Subassemblies for vehicle usage.
Commenting on the achievement, Mr Thomas Fuhrmann, Managing Director, TÜV Rheinland India said, “We are proud to announce the opening of our NABL Accredited Medical Device Centre of Excellence. From Medical Standards interpretation to testing and certification, TÜV Rheinland provides Total Quality Assurance throughout the product life-cycle. We offer regulatory compliance expertise and testing to ensure rapid turnaround times with the highest level of service, and most advanced technologies for analytical, chemical, microbiological, biocompatibility, electrical, mechanical and package testing needs.” He added, “Since our Medical Device Centre of Excellence is located in a MedTech Zone, medical device manufacturers can reduce their overall product developmental phase, logistic charges and thereby improve time to market. TÜV Rheinland acts as a one-stop-solution for manufacturers within the zone as well as this part of the country to have their products tested and certified as per national, international, and customer-specific requirements.”
TÜV Rheinland’s state-of-the-art Biomaterial Testing Laboratory is equipped to analyse and test the nature of biomaterial along with physiochemical, histopathological, and mechanical strength evaluation – both post and pre-implantation, sterility and other related tests. To ensure safe and effective biomaterial products, the Biomaterial Testing facility offers a wide range of analytical capabilities to determine the identity, purity and biosafety of a growing number of biomaterials using the latest testing methodologies to meet safety and quality standards as per local and global regulations. It is also equipped with advanced technology to perform tests on medical textiles including surgical and N95 masks in order to support customers with their regulatory and non-regulatory testing requirements.
To prevent electromagnetic interference and susceptibility, electrical devices have to adhere to Electromagnetic Compatibility (EMC) guidelines. TÜV Rheinland’s Medical Device Centre of Excellence offers a fully equipped EMC testing facility as a one-stop-solution for all immunity tests as per medical and non-medical product categories. Its 10-metre and 3-metre Anechoic EMI EMC Test Laboratory is the only internationally certified facility in India that is accredited up to 40 GHz. It performs tests such as Radiated Emission, Conducted Emission, Radiated & Conducted Susceptibility, Electrostatic Discharge, Surge, Electrical Fast Transients (EFT) and many more. The laboratory has a wide range of environmental test facilities such as Combined Shock and Vibration as well as Thermal Shock Chambers to support manufacturers with their product validations. The A2LA accreditation for EMC Services helps to perform tests locally and is a full-service-solution for entry into international markets. These accreditations are some of our major achievements at the Medical Device Centre of Excellence and have been accredited much ahead of schedule. The semi-anechoic chamber housed in this facility is the largest within TÜV Rheinland globally.
TÜV Rheinland India operates its one-of-a-kind Medical Device Centre of Excellence as per ISO standards as well as guidelines set by the National Health Systems Resource Centre, Government of India with an aim to support its objective to deliver affordable healthcare to every individual by reducing the cost of medical devices, reducing reliance on imports and delivering quality medical devices to the domestic market, with a larger goal of garnering a bigger share of the medical devices export market.