Regulatory navigation program

Regulatory compliance is an essential part of the journey when developing safe healthtech solutions for the European and global markets. It’s a common struggle, entering this new line of business which causes months and years of unnecessary delays in reaching the market.

This series of educational sessions, by Lean Entries, combined with the interactive tool Entries and one-to-one sessions with regulatory experts, serves to navigate faster, minimize risk and overcome some of the hurdles that you commonly face while developing safe health tech solutions for the European and global market.

Find more information about the regulatory program here.

View the sessions here:

• Session 1 – Introduction to regulatory essentials
• Session 2 – Early development and management
• Session 3 – The core of regulatory requirements
• Session 4 – Design control and the regulatory environment
• Session 5 – Medical device software
• Session 6 – Risk management in practice
• Session 7 – Usability and labelling
• Session 8 – Biological and electrical safety
• Session 9 – Clinical evaluation in practice
• Session 10 – Post-market surveillance and post market clinical follow-up
• Session 11 – Regulatory Essentials, FDA
• Session 12 (part 1) Clin Inv Practical Approach
• Session 12 (part 2) Clin Inv GFPR and Data mgm
• Session 13: Regulatory Essentials, PRRC