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Regulatory

We will assist you to efficiently bring innovative medical devices, in vitro diagnostics and combination products to US and European markets.

Learn from
the Experts

The interdisciplinary team of Meditrial’s professionals will guide you through every step of approval and progression of your clinical investigation.

Achieve
Certification

Confirm the obtained knowledge with an official certification. Benefit from this possibility and sign up to Mastertrial.

Let’s start learning together

MDR and
IVDR

Master new Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) with Meditrial team.

Clinical
Trials

Our courses deliver deep understanding of how to design and conduct high level clinical trials.

FDA Regulation for Medical Devices

Thanks to experience working with FDA we provide each and every aspect you need to learn about FDA regulation for medical devices.

ISO 14155:2020
GCP for Devices

Get into a new ISO 14155:20 standards and learn how it can be applied to your clinical trial.

Europe Market
Access

Need to CE-mark your Medical Devices on European market? Study legislative framework and procedures for approval with our team of experts.

Product Guidelines
and Standards

Study novel ISO 22679 regulations and guidelines for transcatheter cardiac occluders.

Digital
Health

Digital Health is new to you? Learn with us more about it!

GDPR

Still having troubles with GDPR? Grasp fundamental concepts and clarify the impact of GDPR on the conduct of clinical trials.

Pharmacovigilance

Pharmacovigilance activities are required from the initial pre-marketing through post-marketing phase of clinical trials. Learn about all particularities of being compliant with current pharmacovigilance regulations in the US and Europe.

Covid-19

Guarantee the continuity of your clinical trials during pandemic is challenging. Here we provide key regulatory guidance released by Competent Authorities for such cases.

Startup and Business Practices

Learn with us a number of practices which will help you to develop your business and get to the top in the field.

We are always creating new courses!

 

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Trusted by Leading Experts in the World of Pharma and Medtech

Struggle filing for a clinical trial?

With our broad selection of course topics you will find the required information for your own success.

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