Analytics and studies for safe medical devices

Makrolife offers specialized analyses, studies, and testing procedures for medical devices, focusing on biocompatibility, product safety, and regulatory compliance. Our services include chemical characterization, biological evaluation, cytotoxicity testing, irritation and sensitization testing, sterility testing, bioburden analysis, endotoxin testing, and toxicological risk assessments according to relevant ISO standards. We support manufacturers and developers of medical devices in the safe evaluation, documentation, and market preparation of their products.

Chemical characterization for safety and conformity (ISO 10993-18)

Chemical analysis according to ISO 10993-18 identifies and quantifies potentially releasable substances in medical devices, minimizes health risks and supports faster regulatory approval.

from EUR 10,200.00

Biological Assessment Report (BER) (ISO 10993-1)

The Biological Assessment Report (BER) summarizes and evaluates study results to ensure a final biological risk assessment.

from EUR 9,200.00

Biological Assessment Plan (BEP) (ISO 10993-1)

The biological assessment plan (BEP) provides a structured framework for assessing biological safety and ensuring compliance with regulatory requirements.

from EUR 7,200.00

Cytotoxicity testing (ISO 10993-5)

The cytotoxicity test according to ISO 10993-5 assesses possible harmful effects of materials on cells and ensures their safety for human use.

from EUR 980.00

Quantitative in vitro cytotoxicity test NRU test (ISO 10993-5)

The NRU test assesses the biological reactivity of cell cultures to material extracts and ensures their safety.

from EUR 980.00

MTT test – Cytotoxicity test for metabolic activity (ISO 10993-5)

The MTT test assesses the cytotoxicity of material extracts by measuring cell activity.

from EUR 960.00

XTT test Quantitative in vitro cytotoxicity test (ISO 10993-5)

The XTT test determines cell viability and assesses the cytotoxicity of material extracts.

from EUR 1,250.00

Skin sensitization test - assessment of allergic reactions (ISO 10993-10)

Examination of the sensitization potential of a medical device within the framework of biocompatibility assessment

from EUR 6,200.00

Irritation test for skin and mucous membrane irritation (ISO 10993-23)

Irritation testing according to ISO 10993-23 assesses the potential of materials to cause irritation upon contact with skin or tissue.

from EUR 1,300.00

Sterility testing – Assessment of microbial contamination after sterilization (ISO 11737-2)

The sterility test according to ISO 11737-2 checks for the presence of microorganisms after sterilization and ensures microbiological safety.

from 950.00 EUR

Bioburden test – determination of microbial load (ISO 11737-1)

The bioburden test according to ISO 11737-1 determines the microbial load on products, raw materials and surfaces.

from EUR 1,200.00

Endotoxin test – assessment of pyrogenic risks and sterilization validation (ISO 11737-3)

The endotoxin test according to ISO 11737-3 assesses pyrogenic risks and supports the validation of cleaning and sterilization processes.

from 670.00 EUR

Toxicological Risk Assessment (TRA) (ISO 10993-17)

The NRU test assesses the biological reactivity of cell cultures to material extracts and ensures their safety.

from EUR 2,200.00

Cleaning validation – Ensuring the reprocessing of medical devices (ISO 17664)

The MTT test assesses the cytotoxicity of material extracts by measuring cell activity.

from EUR 5,160.00

AMES test – Genotoxicity assessment (ISO 10993-3)

The XTT test determines cell viability and assesses the cytotoxicity of material extracts.

from EUR 3,250.00

Mask testing – quality assurance and CE marking (EN 14683)

Examination of the sensitization potential of a medical device within the framework of biocompatibility assessment

from EUR 4,800.00