GLP and ISO 10993-Compliant Biocompatibility and Safety Analyses for Medical Devices

A medical device refers to any instrument, software, implant, reagent, or similar product developed for the purpose of diagnosis, treatment, monitoring, or support, whether used alone or in combination, on humans.

Although these products do not perform their primary function through pharmacological, immunological, or metabolic effects, safety assessment is critical because they come into direct contact with the human body.

In this context, the safety of medical devices is evaluated in accordance with GLP (Good Laboratory Practice), ISO 10993, and MDR (EU 2017/745) requirements.

Biocompatibility Analyses

Biocompatibility tests evaluate whether a medical device is safe when it comes into contact with the human body.

These tests analyze risks such as:

• Irritation and sensitization
• Systemic toxicity
• Tissue damage
• Genetic damage (mutagenicity)
• Other adverse effects.

GLP-Compliant In Vivo Laboratories

In accordance with ethical standards:

• Controlled environment systems
• Pressure-controlled closed chambers
• Studies are conducted using systems that prioritize animal welfare.

ISO 17025-Accredited In Vitro Laboratories

Detailed analyses are performed using modern equipment infrastructure and a specialized team, employing alternative testing methods.

Chemical Characterization (ISO 10993-18)

Chemical characterization is performed to assess the chemical risks a medical device may be exposed to during use.

Within this scope:

• Compatibility with blood and skin
• Material components
• Leakage and release analyses
• Interactions with cleaning chemicals are examined.

These analyses constitute the first and most critical phase of the device safety assessment.

Quality and Safety Analyses

The safety of medical devices is evaluated through comprehensive testing from production to use:

• Microbiological Tests: The biological safety of products is ensured.
• Packaging Performance Tests: Sterility and physical integrity are maintained.
• Residue Tests: Residues from cleaning and post-production chemicals are analyzed.
• Stability and Aging Tests:The product’s shelf life is determined.
• Corrosion Tests: The durability of metal components is evaluated.
• Biodegradation Tests: The degradation products of polymer structures are analyzed.
• Pure Water Tests: The quality suitability of the water used in production is verified.

The safe use of medical devices is ensured not only through design and functionality but also through comprehensive safety tests compliant with GLP, ISO 10993, and MDR.

Through biocompatibility, chemical characterization, and quality analyses, it is scientifically proven that devices are safe for human health, and their market release is ensured in compliance with regulations.