Medical Device Testing & Consultancy

We assist companies with the development and life cycle management of their medical devices, through our global network of regulatory experts, 20+ laboratories, and 2 sterile packaging sites in Europe, North America, & Asia Pacific. Companies of all sizes benefit from our 40+ years of expertise and capabilities to ready their products for market launch and post-marketing activities through three independent services: consulting, testing, and sterile packaging.

Our extensive experience in commercialisation processes, regulatory requirements, and industry trends ensures rapid turnaround of your project with the highest level of service and most advanced technologies.

What do you need to be compliant and where do I begin?  

We can help you with: Biological safety plan, Biological summary report, Gap analysis, Bridging studies, Expert statements, Testing Strategy, Risk assessments.

Medical device testing and consultancy services, the full package

• Consultancy
  • Scientific and Regulatory Support
  • In-house Trainings and Seminars
  • Biological Evaluation
  • Clinical Evaluation

• Medical Device Testing:
  • Biocompatibility
  • Chemical Characterisation
  • Chemical and Physical Analysis
  • Microbiology and Sterility
  • Packaging and Seal Integrity
  • Reprocessing Cleaning Validations
  • Shelf-Life and Product Stability

• Packaging and Sterilisation

Why choose Eurofins Medical Device Services?

• Single point of contact. Benefit from streamlined communication through a single local point of contact while leveraging the advantages of our extensive global network.
• Complete service portfolio. Leveraging our network of regulatory experts, laboratories, and sterile packaging sites in Europe, North America, & Asia Pacific, we can offer a comprehensive service portfolio to our customers.
• Extensive expertise. Companies of all sizes benefit from our 40+ years of expertise and capabilities to ready their products for market launch and post-marketing activities through three independent services: consulting, testing, and sterile packaging.

If you would like to discuss your project and needs with our Business Development Manager Anja Kroon or request a quotation, feel free to contact us.

If you would like more information about our Medical Device testing capabilities, please also visit our global Medical Device website using the following link: https://www.eurofins.com/medical-device/