Why medical device testing?

Medical Devices and Surgical Items are lifesaving products used in Hospitals & individuals to get benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life. It is mandatory to ensure the quality standards to provide absolute testing certainty by delivering accurate and reliable results for our clients of the Medical devices & Surgical Items manufacturers as per the standards set by the regulatory Authorities before going to Market. Manufacturers will ensure and get confirm their Quality of the Medical Devices & Surgical Items from Third-party testing laboratory by NABL / CDSCO / BIS Authorized Testing laboratory, even though they are having own facility at their Manufacturing site. Medical devices testing needs, from small, start-up ventures to large and established manufacturers.

WHO WE ARE? WHAT DO WE DO?

Trustin Analytical Solutions Private Limited is one of the leading Quality Control Medical Devices Testing & Surgical items laboratories, located in Chrompet at Chennai, Tamilnadu, India. It was established by a group of experienced Directors and Technical Professionals on Medical devices testing and Surgical testing to cater/meet expected quality standards all the time without having any issues on consistency in quality standards, reasonable cost, and TAT which is required for all Medical device Manufacturers and distributors. And Trustin Directors and technical heads who have worked in leading contract research Organizations and pharma industries certified by USFDA, UK MHRA, EU GMP, ANVISA, WHO GMP and Notational & International GLP compliance monitoring authorities and have vast working experience with UNFPA, UNOPS, Population Service International and Ministry of Health and family welfare, India &, etc., the Testing facility have been accredited by NABL as per ISO/IEC 17025:2017, approved by CDSCO (MD 40 & Form 37) and Bureau of Indian Standards (BIS). And also our test facility has been approved by UNFPA for the Copper T testing. Testing facility has fully equipped state-of-art modern laboratories and highly sophisticated instruments in Cleanroom environments to meet the expectation of the customers as well as certifying bodies. Trustin Samples storage areas, Testing areas, Documents Archival area, Control Samples area entries are restricted only for Authorized persons access by having biometric access control systems. Testing areas are partitioned by GI Powder-coated PUF insulated cleanroom panels with EPOXY flooring, having a different class of change rooms and Airlocks for unidirectional Men and Material Movements. Also inbuilt design for Material entry and exit unidirectional movement through Static and Dynamic Pass Boxes in testing areas. The microbiological testing lab is having class 100, Class 1000, Class 10000, Class 1 Lakh clean rooms having dedicated Air handling units separately for Sterility testing area by Class 1000, general biological testing in class 10000 handling cultures and Medias in Laminar Airflow and Biosafety units. Testing activities are inbuilt systems by having Sample preparation Procedures ( SPP), standard test Procedures ( STP ), Standard Operating Procedures ( SOP ), validated and qualified area, instruments, equipment with controlled formats for data entering, analyzing, storing data to maintain data integrity as well retrieve the data by our customers anytime in future. Trustin offers various Mechanical, Chemical,( Assay, Residual, Leachability &, etc., ) Biological, Bio-compatibility, and packaging & Transportation testing services as a single point contact service.

Vision

Most trusted Third Party Medical Devices tests service provider for the Manufactures & Government organizations in the field of medical devices and surgical products for Domestic & international markets.

Mission

• Creating a motivate work atmosphere with a quality culture.
• Ensure our customers get the best services always.
1. Getting Accuracy in test reports
2. Delivering reports on time
3. Reasonable Test cost.