Other Services:
Toxicological Risk Assessment (TRA) Reports
Comprehensive safety evaluations integrating both clinical and non-clinical data.
Medical Device Regulation (MDR) Documentation
Expert preparation of technical files in accordance with EMA, FDA, and Turkish Pharmaceuticals and Medical Devices Agency (TİTCK) requirements, specifically in the Summary Technical Documentation (STED) format.
Biocompatibility Assessments (ISO 10993)
Strategic biological evaluation of medical device biomaterials to ensure patient safety.
Cytotoxicity Testing (OECD TG129)
Cell-based assays specifically tailored for the biological evaluation of medical devices.
Skin Sensitization Testing (ISO 10993-10)
Specialized tests conducted to measure the potential for allergic or sensitization reactions.
Dermal Irritation Testing (ISO 10993-23)
Assessment of skin irritation potential to determine the biological compatibility of the device.
Volatile Organic Compound (VOC) Analysis (ISO 18562-3)
Emission testing to evaluate the biocompatibility of breathing gas pathways.
Particulate Matter (PM) Analysis (ISO 18562-2)
Particulate emission testing for devices used in respiratory pathways.
Elemental & Heavy Metal Analysis
High-sensitivity detection and quantification of heavy metals using ICP-MS or AAS instrumentation.
Inflammatory & Anti-inflammatory Profiling
Quantitative measurement of prostaglandins, interleukins, cytokines, and chemokines via spectrophotometric and spectrofluorometric methods.
Oxidative Stress & Antioxidant Assays
Accurate determination of total antioxidant capacity, glutathione levels, and enzymatic activities.
Melamine Quantification
HPLC-based detection of melamine in biological fluids, food, feed, and various commercial products.
Bisphenol A, F & S Analysis
Determination of bisphenol analogue concentrations in products and biological matrices via HPLC or spectrophotometric techniques.
Phthalate Analysis (DEHP, MEHP, DBP)
Comprehensive evaluation of phthalate derivatives in diverse matrices utilizing HPLC or spectrophotometric analysis.