Phone: +9144-22731006 | +91-98400 40883

Our Services

Trustin Analytical Solutions Private Limited is a leading Quality Control Testing laboratory for Medical Devices, Surgical & Pharma Industries located in Chrompet at Chennai, Tamilnadu, India. It has fully equipped with state-of-art modern laboratories and highly sophisticated instruments to meet the expectation of the National & International customers as well as certifying bodies.

Trustin Analytical Solutions Private Limited aims to provide its value to customer satisfaction in terms of Quality, Commitment and reliability and the fastest delivery times. It aims to work with a strong customer orientation and intends to keep itself as a company which is approachable and always available for a response.

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.

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MICROBIOLOGY
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Mechanical

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Packaging

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Stability
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Qualification & Method Validation

Features of Medical Device Testing

Mandatory for every Manufactures 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. Medical devices testing industries are keep growing, not many players. Can expand our business globally whatever and wherever we like & Set unique filed.

The difference from other Medical device testing Companies

  • All Medical devices & surgical items testing can be done in singe Roof for Mechanical, Microbiology, Chemical & Packaging, and Transportation test.
  • Medical Devices and Surgical items testing for Mechanical & Microbiology with NABL, MD - 40 & BIS approvals is not available in the South.
  • All functional heads are stack holders and having more than two decades of exposures in the Medical devices testing in many MNC companies.
  • Having Strong knowledge, exposures in the implementation of quality and safety systems in a straight way forward without dilution by every functional head.

Quality and Timing

  • Creating a motivating work atmosphere with a quality culture which will ensure our customers to get the best services by getting accurate and reliable results always
  • Reducing the testing cost, hence our testing cost is very reasonable and less compare with other testing labs.
  • Always marinating and committing on-time delivery.

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.

provider in Single roof for the following products

  • All categories Class A to D of Medical Devices ( Catheters, Orthopedic implants, Intraocular lenses, Cardiac Stents, Heart valves, Urological Devices, Respiratory Devices, Disposable hypodermic Needles, Disposable hypodermic Syringes
  • Disposable Perfusion sets
  • internal Prosthetic replacements
  • IV Cannulae & etc.
  • Disinfectants, UV Light, Sanitizers & Hand wash ( Assay, Sterility and Antimicrobial activities )
  • Surgical and Examination Gloves
  • Nitrile Gloves
  • Surgical dressings, Gauze & Bandages &, etc.,
  • Blood Bags and Transfusion sets
  • Male and Female Condoms
  • Female contraceptives (Copper T & Tubal Rings),
  • Absorbable & Non-absorbable Sutures
  • Sanitary Napkins
  • Rubber Stoppers

Test will perform as per National & International standards like IS / ISO / ASTM / EP / USP / IP / customer In-house method. Trustin also carries out sterile barrier system shelf life validation which includes the machining process, the effects of the Sterilization process, Environmental challenges, Distribution, Handling, and Shipping events (Transportation Test) by conducting the accelerated stability study as per ASTM F 1980. Trustin performing the package integrity validation process by using the testing parameters such as Sterility, Sterility validation, Bio-burden, Antimicrobial Test, UV Efficacy Test, Pathogen Identification Test, Bacterial Endotoxin Test in the Microbiology Testing facility. Trustin carries out the tests such as Bursting strength, Peel strength, Package Integrity, Hanging sheer weight, Tear strength, Tensile Strength & Adhesive Strength in the Mechanical Testing Facility. Also, it offers Bio-compatibility studies like In-vitro cytotoxicity, Skin Sensitization, Skin Irritation & Pyrogen Test for the Medical devices and surgical items.

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.

MEDICAL DEVICES TESTING

Our Main Focus is to reduce testing time, cost & ensure on time deliveries

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