Understanding Medical Device Regulations for Software Products


Are you developing medical devices with software components?

Attend our training course to ensure the health of your business and patient by learning how to navigate the regulatory pathway to market

This course will demonstrate how the medical device regulations apply to your software. You will learn

  • Does your software qualify as a medical device?
  • How your software is classified
  • How to identify relevant directives, standards and guidance documents you need to develop your device according to the state of the art
  • How to develop and maintain your device for the EU market (CE mark), including design & development, quality management, compilation of technical file, conformity assessment, vigilance and post market-surveillance

Event details

Date:          Thu, 2 May 2019

Time:         10:00 – 16:00 BST

Place:         Thorpe Park Hotel & Spa, 1150 Century Way, Leeds, LS15 8ZB

For registration, please click here: Understanding Medical Device Regulations for Software Products.

For further details, please contact Dr Clare Lankester at clare.lankester@medipex.co.uk or call 07498 320922.