Tailored advisory for Medical Devices.
In compliance with the MDR
The EU Medical Device Regulation 2017/745 (MDR) brings stricter standards for quality and safety in medical devices, including demand for detailed technical documentation in toxicological risk assessment and clinical evaluations.
Our expert team provides support from product development through post-market surveillance in different areas to enhance your safety evaluation of medical devices.
Key services
Biological Evaluation
- Biological Evaluation Plan
- Biological Evaluation Report
- Interpretation of Biocompatibility test results
- Toxicological Risk Assessment of E&L
- Gap Analysis
Clinical Evaluation
- Clinical Evaluation Plan
- Clinical Evaluation Report
Combination Products & Substance-based Medical Devices
- Pharmacological appraisal for functional ingredients and rationale for the qualification of the product as a device
- Justification for the classification of Medical Devices
Relevant standards and regulations:
*MDR 2017/745
*MDCG-5, -6, -13
*MEDDEV
*SSCP
*ISO 7405
*ISO 10993
*ISO 14971
*ISO 18562
The expert team
With profound knowledge in toxicology and pharmacology, the ToxHub team of experts offer tailored solutions for regulatory compliance and ensure the utmost safety of your devices.
