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We perform medical device testing in compliance to as per FDA, CE, ASTM, and ISO guidelines. Also provide best solution for biocompatibility testing, stability testing & clinical evaluation of medical devices.

In era of Medical Devices, Implants, IVD and Drug-Device Combination Products; Medzus Laboratories services start with product design & development to batch release.

Our medical device services start from product design & development to batch release; we specialize in product assembly, packaging, sterilization & testing. We use & apply various different techniques, machines & instruments for successful launching of your requirement with considering international harmonized standards. Also helps you to makes your idea workable for customized application.

We involved in various application of Force, Torque and Leakage testing in Medical devices. Our services help in test method development, method validation, process optimization & process validation.

We specialize in calibration & testing services for all small-bore connectors specified in ISO 80369-1 to 7 & 20. We are able to help for customized testing application to makes your idea workable.

Medzus Healthcare

Medzus Laboratories, a Medical Device, IVD and Drug –Device Combination Product expert located in the heart of Vadodara, Gujarat, India.

Medzus Healthcare, the root company was established in 2012 and bought up with providing various technical services to healthcare & pharmaceutical industries.

Development & Testing

Medzus Laboratories has a dedicated unit focused on providing support and testing for compliance with combination product related regulatory standards. The FDA & ISO Guidance document entitled "Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products" recommends that the final injector for submission undergoes a variety of performance tests, including, but not limited to:

Drug -Device Combination Products

Combination product testing for all types of applications, and can provide comprehensive testing services to support your regulatory submission, as well as design verification, method feasibility and validation, and routine analysis services.

Medical Devices

We specialize in design, development & testing of various Disposable Medical Devices, In- Vitro Diagnostic Devices & Combination Products/Drug Delivery Devices.We treat the whole project with Good Design Practice

Implants

We test implants during the development phase or for approval according to ASTM- or ISO standards - or following custom testing procedures adapted to the specific requirements of your medical device.

In-vitro Diagnostic

Effective project management, tying together your internal organization, development partners, suppliers, Notified Bodies, and regulatory agencies

Electrical Medical Device

Worldwide medical electrical equipment and in vitrodiagnostic medical devices are controlled by strictly regulated National and international approval procedures which include testing, certification and audit requirements.

ISO 11607 Package Testing

Packaging system for terminally sterilized medical devices is to enable the sterilization physical protection and preservation of sterility up to the point of use and to provide an aseptic presentation.