Medical Testing laboratory Services 

01

Package validation

Medical Devices Packaging System Validation as per ISO 11607

02

Clean room validation

Validation Activities as per ISO 14644 requirements

03

Residual EO/ECH Analysis

Testing activity as per ISO 10993-7

04

Biocompatibility Testing Services

Testing against the following standards 

Hemocompatibility testing ISO 10993-4

Cytotoxicity testing ISO 10993-5

Intracutaneous irritation testing ISO 10993-10

Sensitization testing ISO 10993-10

Systemic toxicity testing ISO 10993-11

05

Ethylene Oxide (EO) Sterilization Validation

Validation Activities as per ISO 11135 requirements and AAMI TIR 15 Read more >>

06

Packaging Accelerated Aging Studies

Packaging System Aging study as per ISO 11607 and following ASTM F1980

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Roald Dahllaan 33 , 5629MC , Eindhoven , The Netherlands 

Whats-app +31685008887

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A European Authorised Representative (E.A.R.) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives/Regualtions

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