Regulatory

Coming Soon:

• New (UDI) Unique Device IDentification requirement in compliance to new EMDR
• New Technical File structure according to new EMDR

Hot Topics:

• Biological Safety of Medical Devices according to ISO 10993 – Live Webinar
• Medical Devices Sterilization Methods – Live Webinar
• Medical Device Directive 2016 – NEW EU Medical Device Regulations – Training – Live Webinar

Commented Presentation:

• Introduction to Medical Device and regulations – Webinar Course
• Clinical evaluation of medical devices for regulatory compliance – Webinar Course

 

Free Resources:

MAJOR EU REGULATIONS (MDD, IVD, AIMDD)