+49 89 899 650 0   mdsales@eurofins.com  www.eurofins.com

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Medical Device Testing

Our Services at A Glance

Chemical / Physical Analysis

Extractables & Leachables
Material & Product Stability
Raw Materials Purity
Particle Characterization
Residual Ethylene Oxide

Microbiology & Sterility

Sterility / Sterility Validations
Bioburden / Bioburden Validations
Endotoxins / Endotoxin Validations
Antimicrobials / Infection Control
Cleaning & Reprocessing Validations
Bacterial Identification
Customized Test Designs

Packaging Validation & Seal Integrity

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

Biocompatibility Testing

Hemocompatibility (Hemolysis, Coagulation, Platelet Count etc.)
Genotoxicity (AMES, Mouse Lymphoma Assay, MNT etc.)
Systemic Toxicity (acute, subacute, chronic, subchronic)
Implantation (standard, customized, functional)
Degradation Studies

Chemical Characterization

GCMS +/- Headspace, ICP, LCMS, FTIR
Toxicological Risk Assessment
Expert Evaluation
Inclusion of AET

Combination Products

Drug Release and Dissolution
Chemical Compatibility
Container & Closure Integrity
Syringe Testing

Mechanical Implant Testing

Material Tests, i.e. Physical Testing (Compression, Tension, Shear)
Characterization of Coatings
Particle Analysis and Ion Release Tests
Corrosion Testing
Finite Element Analysis

Medical Electrical Equipment

EMC and Safety tests for active medical devices according to IEC 60601 (CB-Scheme)
Tests for RED requirements

Notified Body Services

CE Certification


Seminare & Webinare

Consulting - Professional Scientific Services

Our consulting team is at your disposal with the highest scientific consulting competence in the testing of medical devices, pharmaceuticals and chemicals. From the market launch to the re-evaluation of existing products.

We offer solutions and strategic approaches for complex toxicological or regulatory problems. Requirements change quickly, we are always up to date and with our regulatory expertise in global markets we bring clarity to your process.

You can make more effective use of time and costs and thus achieve the best possible results through our advice right from the start of your entire product development. We provide expert statements, carry out a risk assessment for your product and support you in your test strategy planning.

The consulting services of the individual experts enable you to reduce your product development risks to a minimum and bring your products to market faster and more efficiently.
We are recognized for our integrity, professionalism and ability to cross sectors and build bridges. Our corporate value is our commitment to customer service.

Eurofins BioPharma Product Testing Munich GmbH

Robert Koch Strasse 3a

82152 Planegg/Munich



+49 898996500