Clinmark experienced team supports formulation of regulatory strategies and study designs of medical devices and in-vitro medical devices in all kinds of indications. The entry into force of the Medical Device Regulation (MDR) 2017/745 and the In-Vitro Medical Device Regulation (IVDR) 2017/746 result in changes to the existing requirements for medical devices. The new regulations apply to clinical trials necessary to introduce products to the market as well as post-marketing studies. Also, the recertification of products already present on the market may require new clinical trials in accordance with these regulations.
We will help you to set up a clinical trial tailored to your medical device-specific needs and support you at each step:
- Selection of the appropriate regulatory pathway for a given medical device
- Clinical strategy/Study design
- Medical writing
- Feasibility process
- Submission of the application for conducting clinical trial to EC and RA
- Interactions with Regulatory Authorities, EC and notified Bodies
- Clinical data management
- Clinical project Management
- Monitoring
- Safety – vigilance and reporting
- Biostatistics