Workshop: Basics of Regulatory Affairs in Medtech (MDR, IVDR)

Get an overview of the regulatory landscape, hear about the basic concepts and principles and get insight into the necessary steps but also pitfalls when bringing a Medtech product to the market. Discuss with the experts. 

 

This training provides you with the basics of regulatory affairs in Medtech with the focus on MDR and IVDR (Medical Devices and In-Vitro Diagnostic Medical Devices Regulation). Get an overview of the regulatory landscape, hear about the basic concepts and principles and get insights into the necessary steps but also pitfalls when bringing a Medtech product to the market. Discuss with the experts. 

Training Objective 

• Get an overview of the regulatory landscape and regulatory stakeholders in Medtech
• Understand the major principles, concepts and processes
• Learn to sequence the necessary steps and build awareness of possible pitfalls when bringing a Medtech product to the market
• Know where and how to find required information

Target Audience 

• Researchers in the field of translational medicine
• Employees from spin-offs, startups and SMEs, who intend to bring a product to the market
• Employees from companies interested in getting an overview on regulatory affairs
• Investors in medical devices who would like to understand risks and opportunities regarding the evolving regulatory framework in EU

Prerequisites 

• Affinity to or involvement in Medtech or Life Sciences
• Basic understanding of Good Practices in product development and innovation
• Technical / scientific background or commercial background linked to Life Sciences products

For detailed programme see www.standort.zh.ch/WS-RA

The workshop is a joint initiative of the Division Business and Economic Development (AWA) of the Canton of Zurich, ETH Zurich Industry Relations and Life Science Zurich Business Network. Expert speakers will come from Medidee Services AG.