Developing Medical Device Software to IEC 62304

| Ideas & Opinions

Medical software design standard IEC 62304 came into force in June 2010 and is now regulatory. Triteq Technical Director Ken Hall, was asked to share his views by emdt magazine and his article describes how the standard will impact the software development process for medical device manufacturers.

Standards for medical device design

“Until recently, safety regulations for medical device software, at least formally, were not exceptionally rigorous across the board. In addition, software was not formally classified as a medical product by the Medical Devices Directive. This has now changed. A new regime is in force governing all medical device software development for all classes of device.”

                                                  

Leave a Reply

Your email address will not be published. Required fields are marked *

product design & development for:

Venturefest Oxford 2017

Over 500 delegates attended VentureFest Oxford 2017 this week, which was themed “From Start-Up to Scale-Up”. This excellent event brought together innovative start-ups, SME’s, investors and established Oxford success stories in a collaborative and learning environment. Angela Hobbs, Triteq’s Managing… more

Congratulations to Travis Wentworth for winning The Triteq Young Entrepreneur Award

Young Entrepreneur Award – The Triteq Young Entrepreneur Award recognises and celebrates the best young founder/s (under 40) of science and technology companies in the region, as demonstrated in the 2016–17 Venturefest Oxford pitching programme, which includes Pitchfest and Pitching… more

Life Science Innovation Showcase

This is your opportunity to engage with industry-leading figures at this exclusive exhibition, and network with specialists in attendance from across the Life Sciences eco-system.

View all events