One-stop-shop solution to meet all your global regulatory challenges
With a strategic focus on quality and personal service, Eurofins Medical Device Testing supports medical device clients to ensure the safety and efficacy of their products by delivering unparalleled testing and consultancy services with complete, compliant and accurate data for over 40 years.
Why choose our consultancy services?
We constantly monitor the developments of the regulatory aspects assuring an exhaustive fulfillment of your designated obligations as a manufacturer. Our consulting expertise in the field of medical devices enables us to advise you which regulatory framework is applicable and how regulatory compliance can be achieved
What do we offer?
Microbiological contamination control in clean controlled environments
- Support with NEN-EN 17141:2020
- Setting up or reviewing of Environmental Monitoring program
- Perform gap-analysis between EM program and NEN-EN 17141:2020
- Evaluation of EM data and House flora strains
- Evaluation of Cleaning procedure
Biological Evaluation
- Biological risk Assessment (also for combination products)
- Biological Evaluation Plan
- Biological Gap Analysis
- Biological Evaluation Report
- Chemical Characterization testing strategy
- Toxicologial Risk Assessment (raw materials, extractables and leachables)
- Change assessment
- Assessment for Endocrine disruptor
- Regulatory issues (NB or FDA non-conformity)
- Management of unexpected data
- Q&A sessions with our experts
Clinical Evaluation
- Clinical Evaluation Plan
- Literature review
- Identification and appraisal of pertinent data
- Clinical Evaluation report revision
- Support in filing clinical evaluation report
Regulatory Affairs
- Classification of MD according to MDD/MDR
- Technical File compiling
- 510(k) compiling
- Risk management
- Literature review supporting equivalence, claims and mechanism of action
Training
- In house training
- Webinars
If you want to discuss your project 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/
