Medical devices

Testing and consulting for the medical devices industry

A single laboratory with all the required testing services

MCI is positioned as your strategic ally to guarantee microbiological quality in the manufacturing of medical devices.

We offer specialized analysis, consulting on a wide range of topics and validation of critical environments, ensuring compliance with international standards and contributing to the success of your operations.

We meet the analytical control needs of the medical device manufacturing industry under high quality standards.

We perform all laboratory tasks, from sampling, complete analysis, to the final report. We comply with a fully implemented quality system in all work phases and based on the requirements of the international standard INTE-ISO/IEC 17025:2017.

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Microbiological testing

Environmental monitoring (viable particles in ambient air and on surfaces, and non-viable particles in ambient air)
Gases and compressed air testing (viable particles, non-viable particles, oil and humidity)
Water and alcohol testing (heterotrophic count, bacterial endotoxins, bacterial spores)
Medical devices testing (bioburden, bacterial endotoxins, microbial identification, and sterility, among others)

Environmental analysis

Water analysis: wastewater, drinking and process water.
Analysis of emissions in boilers, direct and indirect furnaces according to legislation.
Analysis of immissions, air quality and occupational exposure to acids and organics.
Microbiology analysis in foods and surfaces.
Analysis of residual ethylene oxide and 2-chloroethanol.

Raw material testing

Alcohol purity analysis, cyclohexanone.
GC-MS chromatography analysis to identify impurities.
Material identification analysis using the FTIR technique.
Gas purity analysis (O2, N2, Ar, among others)
Analysis of mixtures for coatings.

Consulting and training

Basics of industrial microbiology.
Environmental monitoring and biocontamination control program.
Product testing: bioburden (ISO 11737-1) and sterility (ISO 11737-2)
Qualification and routine monitoring of sterilization processes.
Validation of clean rooms, compressed air systems and water purification systems.
Management of product acceptance levels and environmental monitoring.
Quality audits.

Case study projects

Identification of contaminants found in medical devices.
Identification of residual solvents in medical devices.
Identification of residuals for washing processes and support in validations.
Adaptation of the method system by adapting a testing service to your requirement.
Support in validation of solvent mixtures, washing protocols, characterization of process water and vapors.

Medical devices

Testing and consulting for the medical devices industry

Microbiological testing

Environmental analysis

Raw material testing

Consulting and training

Case study projects

Viable particles analysis in air and surfaces

Non-viable particle monitoring in air

Compressed air testing and other gases analyses

Bioburden testing

Bacterial endotoxin testing

Drinking and process waters testing

Microbial isolates characterization

Biological indicators sterility testing

Culture media for different purposes

Samples incubation

Alcohol testing

Labware sterilization and depyrogenation

Calibration of SAS Air Sampler

Ethylene Oxide residue analysis

Consulting and training services

High quality standards

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