Are you developing a medical device with software components?

Attend Medipex’s training course at Thorpe Park Hotel in Leeds, 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

The course will be delivered by Koen Cobbaert, Chair of Software Focus Group at COCIR and Senior Manager for Quality, Standards and Regulations at Philips. Koen has over 15 years experience in medical software; including in establishing regulatory strategies and bringing products to market.

The workshop will be beneficial to industry representatives, clinicians and academics

Delegate fee £295 + VAT, includes course information pack, lunch and refreshments throughout the day.

Please email Clare Lankester (clare.lankester@medipex.co.uk) to book.