Advisory Services for Medical Devices.
In compliance with the MDR
The EU Medical Device Regulation (MDR 2017/745) sets higher standards for the safety, performance, and quality of Medical Devices. It requires more comprehensive technical documentation, ranging from toxicological risk assessments to clinical evaluations. In this complex regulatory landscape, expert advisory services for Medical Devices can make all the difference.
From development to post-market surveillance, our experts help you strengthen the safety evaluation of your Medical Devices. We support you throughout the entire product lifecycle, enabling you to meet MDR requirements with clarity and confidence.
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
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.
