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Your email address will not be published.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:

Siemens gets CE-Mark for new diagnostic solution

Siemens Healthineers has received CE-Mark for its new Atellica Solution with immunoassay and chemistry analysers, which will allow commercial launch in Europe. The flexible, scalable, automation-ready in-vitro diagnostic (IVD) solution is designed to provide control and simplicity to diagnostic professionals,… more

Synaptive Medical introduces new surgical robotic device

Canadian firm Synaptive Medical has introduced its second-generation, high-powered Modus V digital microscope that has a robotic arm to aid neurosurgery. Modus V is based on Canadarm technology used at the International Space Station and is part of the firm’s… more