Learning Marketplace

Understanding Changes to EN-60601 and How to Maintain MDD Compliance

This webinar will provide a high-level overview of the standard IEC 60601-1, the structure of the family of standards, and the key changes introduced by the third edition of the standard including title, risk management, electrical safety, mechanical safety, and thermal and fire safety. We will also explore the Medical Device Directive harmonization and how this affects maintaining compliance with the MDD.


Mr. David Adams MSc CPhys MInstP, MIET

Learning Objectives

  • Gain an understanding of some of the key changes to EN 60601-1 introduced by the third edition
  • Understand the harmonization status of the EN 60601 family of standards
  • Understand what is required to maintain compliance with the MDD for new and existing products

Who Should Attend

  • Regulatory Affairs Specialists
  • Managers and Engineers involved in establishing or maintaining Testing and Compliance
  • Managers of QA/RA
  • Regulatory Consultants

System Requirements

  • Internet Explorer 7 and higher
  • Pop-up blockers should be deactivated when launching online courses
  • Flash -There are certain components of the system that utilize Flash for presentation
  • Adobe Acrobat Reader should be installed to access course completion certificate and presentation documents
  • Browser must be Java and JavaScript enabled