Obtain regulatory approval in the European union and run clinical studies for medical devices in Europe

With the new MDR regulations the legislation has been tightened even further and presents a big challenge for Asian companies that want to utilize their innovations in Europe.

Getting the foundation for the product approvals in place, finding the right notified body, creating the right setup for managing the products in accordance with the regulations is key to successfully launch and develop products in the European market.

Qmed and CCRC Medtech, has partnered up to present a live webinar, specifically for Asian companies that want to understand how to approach the European market, either with product registrations, running clinical studies, or who are interested in the key points and requirements to enter the EU market.

We will have three speakers, who will give their expert take on what you need to know to successfully plan and enter into the European market, with all its opportunities and pittfalls.

Learning objectives

• Understand the overall process of registering a medical device in Europe
• Identify the key factors that can influence the regulatory strategy
• How to utilize the already existing data from Asian run studies and preparing the right clinical plan for getting the regulatory approval
• How do you plan the technical setup of a study in Europe, which sites to choose, which countries, we will provide inspiration, on how to optimize on costs and efforts.
• What does “state of the art” mean and how does it impact your preparations and setups.

The agenda for the webinar:

5 min – Opening remarks with Shawn Ho

20 min –Introduction to the regulatory requirements in the EU (Helene Quie)

25 min – How to get your products registered in EU and clinical development (Søren Underbjerg)

25 min – Running clinical studies in the EU, and the requirements (Stephanie John)

15 min – Open discussions and Questions and answers

The Speakers

Helene Quie – CCO and founder of Qmed Consulting

Shawn Ho – Sen. Business Development Director of CCRC Medtech

Søren Underbjerg – Team Lead Clinical development at Qmed Consulting

Stephanie John – Vice President of Clinical Affairs at Qmed Consulting

Sign-up below for the event and contact us at info@qmed-consulting.com for more information: