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It covers the activities related to the design, classification, production, placing on the market, placing into service and inspection of Medical Devices and Medical Pharmaceutical materials in order to determine the basic requirements that Medical Devices and Medical Pharmaceutical materials must meet and to ensure that patients, practitioners, users and third parties are protected against hazards that may arise in terms of health and safety during the use of these devices and their accessories. (CE Program – Medical Devices Directive EEC/93/42)

Hygienic adequacy of production facilities and devices, microbiological tests on products before and after sterilization and screening of contaminants that may be left behind from the sterilization process (Endotoxins, Ethylene Oxide) should be carried out.

We provide testing services to test and verify the conformity of medical devices according to specified criteria in order to declare that the product meets the mandatory requirements of medical device directive.

Material selection and risk analysis before the production of medical devices is an important part of the design process for medical devices.

With the revision to the ISO 10993-1 standard, it is stated that in the risk assessment process, the definition of the chemical components of direct and indirect contact medical devices and material characterization, including chemical characterization, should be performed.

ISO 10993-18 Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process

Chemical characterization with an suitable toxicological assessment will be taken into account to determine whether further testing is required (ISO 10993-17 and ISO 10993-18). Based on the proposed revisions, the chemical characterization of a medical device provides the necessary data for the biological assessment and toxicological risk assessment of the device.

Tensile & Breaking

A number of experiments and observation procedures such as adhesion strength, sealing strength, adhesion width, visual deformation of packaging materials are carried out.

Accelerated Aging

Stability tests are generally performed to determine/verify the shelf life of the product. In stability tests, it is expected that there is no deterioration in the physicochemical structure of the product and that it is microbiologically acceptable.

Package Performance Tests

It is the test performed to check whether the sterilized and product package is closed in according to the standards.

Bacterial Endotoxin (LAL) Analysis

In short, an “endotoxin” is a structural component of bacteria.

BI Sports Test

The biological indicator is made to detect the number of bacterial spores.

BI Sterility Test

For the control of sterilization systems, it is performed to check whether the indicator placed in the sterilizer is sterile after the sterilization process.

Population Of Microrganism Bioburden Analysis

It is a microbiological analysis performed after the production of medical devices and before the sterilization process.

In Vitro Cytotoxicity Analysis

These are the analyses performed to evaluate the in vitro cytotoxicity (cellular toxicity) of medical devices.

Sterility Analysis

Following the sterilization process of medical devices with different methods, tests are performed to check the accuracy of the sterilization process.

Detergent Residue Analysis

Detergents are used to clean residues such as oil, auxiliary materials, microbiological contamination used in production processes.

Ethylene Oxide Residue Analysis

Sterilization with ethylene oxide is one of the sterilization methods of medical devices.

Corrosion Analysis

These are the corrosion tests to be applied to the metal parts of the instruments made entirely of stainless steel or metallic coated material used in the medical field and medical devices containing parts made of this material in their structures.

Oil Grease Residue Analysis

Some oils are used during the production of medical products. These oils must be cleaned during the production process.

Toxicology assessments and toxicological risk assessments are performed by our toxicologists to help understand the safety profile of your medical device.

According to ISO 10993-17, they identify and assess all toxicity and human exposure risks that exist for Medical Device Testing, the final product and individual chemical compounds.

ISO 10993-17:2023 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents.