With extensive knowledge of the commercialization process, regulatory requirements and scientific trends in the Industry, Eurofins Medical Device Services offers regulatory compliance expertise and experienced GMP/GLP/ISO 17025 testing to ensure rapid turnaround times with the highest level of service and most advanced technologies for your analytical chemical, microbiological, biocompatibility, mechanical and package testing needs. 

Our scientists and engineers have been assisting companies, large and small, with developmental testing for more than 40 years; and our global network of >20 laboratories in North America, Europe and Asia Pacific provide extensive capacity and the highest level of instrument technology with a full scope of testing services.

Chemical / Physical Analysis

• Extractables & Leachables
• Material & Product Stability
• Dissolution
• Raw Material Purity
• Particle Characterization
• Residual Ethylene Oxide
• Mechanical Testing
• Method Development/Validation

Microbiology & Sterility Testing

• Sterilization Validations
• Sterility
• Bioburden
• Endotoxins
• Antimicrobials/Infection Control
• Cleaning & Reprocessing Validations
• Microbial Identification

Electrical Medical Equipment

• Cyber Security
• Safety & Performance Testing

Combination Products

• Drug Release & Dissolution
• Chemical Compatibility
• Container Closure Integrity
• Syringe Testing
• Ophthalmic Testing

Biocompatibility Testing

• Chemical Characterization
• Toxicological Risk Assessment
• Cytotoxicity
• Sensitization
• Irritation
• Acute Systemic Toxicity
• Pyrogenicity
• Subacute/ Subchronic/ Chronic Toxicity
• Genotoxicity
• Implantation
• Hemocompatibility

Human Factors

• Formative Usability Studies
• Human Factors Validation Testing
• Summative Testing
• Labelling Comprehension Studies
• Bridging Studies
• Threshold Analyses
• Heuristic Analyses
• Comparative Use Testing
• Competitive Benchmarking
• Human Factors Strategy
• Human Factors SOPs
• FDA Meeting Planning
• HF Integration Plans
• Use-Related Risk Analysis (URRA)
• Use Specifications
• Labelling Development
• HF Remediation Plans
• Gap Analyses
• Threshold Analyses
• Expert Reviews

Packaging Testing

• Sterile Barrier/ Seal Integrity Testing
• Package & Transit Testing
• Shelf Life: Real Time & Accelerated Aging
• Label Durability
• Container Closure Integrity

Viral Inactivation

• Origin of the source species
• Type of organ, tissue, fluid
• Possible contaminants of the raw material, donator, etc.
• Possible contaminants due to manufacturing process (reagents, manipulation)
• Pathogenicity of the contaminants, type of implant/application
• Amount of «tissue» needed in order to produce a single unit of finished product
• Inactivation step/s during the manufacturing process