Medical Devices

Medical devices vary greatly in application and complexity, from surgical implants to computerized diagnostic tools. They are subject to specific regulations for evaluations of biocompatibility, sterilization and physical-chemical control.

Mérieux NutriSciences offers a comprehensive portfolio of services for the development and registration of medical devices. We perform a complete range of laboratory tests to ensure the quality and safety of medical devices according to current harmonized standards.

Our expert teams also provide specific method development and validation for all medical device requirements.

Biocompatibility evaluation
•    Cytoxicity
•    Acute toxicity
•    Genetic toxicity
•    Irritation or intracutaneous reactivity
•    Skin sensitization

Microbiological control
•    Bioburden determination before sterilization
•    Sterility testing and validation
•    Endotoxin testing by kinetic-turbidmetric or chromagenic methods
•    Bacteriostasis and fungistasis testing
•    Environmental monitoring of production zones

Sterilization services
•    Bi-sterility testing
•    Product innoculation
•    Sterilization validation by radiation

Physico-chemical tests
•    Physico-chemical characterization of medical device materials
•    Leachables and extractables testing
•    Device shelf-life and accelerated aging test
•    RoHS compliance analysis
•    Physico-mechanical tests

Multidose preserved contact lens product testing
•    Efficacy of antimicrobial preservation
•    Cleaning effectiveness
•    Disinfection efficacy (bacteria, fungi, virus, spores, myobacteria)
•    Cytoxicity
•    Occular irritation

In addition to medical device evaluations, Mérieux NutriSciences provides value-added services such as regulatory and scientific support, strategic communications audits, publication plans and more.