Life Science: The Regulatory Journey

The Regulatory Journey offers a targeted learning process with a focus on medical software, medical devices (MDR), and equipment for in vitro diagnostics (IVDR) and.

• A course that provides access to crucial regulatory understanding of legal requirements for getting a medical product to/on the market
• A course that uses both educational tools, sparring with experts, and online teaching
• A space of opportunities where you will be equipped to face the European market at the right time and place

‍"It has been an enriching process with well-chosen experts. I was impressed by the regulatory tool, whichwas very educational and easy to understand.”

Quote The Regulatory Journey 2022

The objective of the program is to provide the teams with the necessary baseline knowledge regarding regulatory compliance, in order to save months’ worth of time and effort in reaching the market. The concept combines digital training and coaching methods which will be employed in the kick-off event and throughout the following three months of the program.

The program is framed around a new regulatory service concept developed by the Danish Life Science Cluster, Accelerace and Symbion in collaboration with Lean Entries and Danish regulatory experts.

• Kick off and introduction: March 13^th in Odense, March 14^th in Aarhus, March 15^th in Copenhagen.
• March 16^th – May 16^th. Online webinars on specific regulatory subjects.
• March 27^th: First workshop. Symbion, Copenhagen
  Get familiar with the tools. Sparring with regulatory experts.
• May 25^th: Final workshop. Symbion Copenhagen.
  Present your regulatory strategy and get feed-back from experts.

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