Understanding Medical Device Regulations for Software Products


Are you developing medical devices with software components?

Attend our training course, delivered by an industry expert, to learn how to navigate the regulatory pathway to market to achieve benefits for your business, patients and the healthcare industry.  

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 the full programme, see copy of the Agenda.

For registration, please go to our Eventbrite booking page.

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