MEDITRIAL HELPLINE SUPPORTS CLINICAL TRIALS DURING COVID-19 EMERGENCY
As your reliable and trustworthy partner, we at Meditrial, have taken extraordinary measures to be always at your side and support you and your peers during the time of the COVID-19 emergency.
That´s why we set up a Meditrial FREE HELPLINE, a tool to facilitate the communication with our teams and address any particular questions or new requirements that may arise from the current situation.
We understand the criticality of supporting all parties involved in important research programs. For this reason, we are implementing actions to minimize disruption and carry on our clinical mission.
Thanks to advanced technology and digital tools, Meditrial teams will continue to be responsive to reassure on any issue you may encounter in the current situation.
Please feel free to contact us immediately, if you need any assistance or have questions regarding your clinical programs or other unexpected business changes you may be experiencing.
What is the impact on clinical research in Europe?
We have created a dedicated Meditrial Forum, helpline@meditrial.net
This forum will distribute updates on European countries’ governing bodies and leading research centers to identify solutions for challenges such as ensuring proper patient follow-up and study monitoring.
What is the impact on the MDR timeline?
The Medical Device Regulation will not be delayed. Meditrial teams are available to provide you with remote support, trainings and templates to accelerate your readiness.
In the spirit of true partnership, we are confident that through collaboration, and resiliency we’ll be able to handle this testing situation effectively. You can rely on us. Together, we move forward.
Need more information? Call Meditrial Helpline +1-800-901-4286 or email us helpline@meditrial.net
Table of Contents
Build a Defensible Clinical Evidence Strategy Under EU MDR
Build a defensible clinical evidence strategy under MDR Annex XIV, from the clinical evaluation plan to PMCF and notified body review.
Getting a CE mark for medical devices: a step-by-step guide
Practical guidance on the CE mark for medical devices under EU MDR, from classification and evidence to conformity assessment and EUDAMED
A Practical RBQM Framework for Medical Device Trials
Risk-based quality management for medical device trials, with practical actions for risk assessment, monitoring, data review, and trial oversight
EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
EU breakthrough medical devices gain a clearer regulatory pathway under MDCG 2025-9, with early advice and lifecycle evidence planning
What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
FDA Breakthrough Device Acceleration
How innovative MedTech companies can accelerate FDA approval, secure Medicare coverage, and reach patients faster—starting with Breakthrough Device Designation.
This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
