Understanding Medical Device Regulations for Software Products
Are you developing medical devices with software components?
Attend a training course delivered by Medipex 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
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