Pressures of software for medical devices

Dec. 2, 2011 - PRLog -- In the medical device industry, the issue of software design is an important one. It can not only improve homogeneity and streamline processes, allowing for increases in safety and production, but also has to comply with a strict range of ever-changing and evolving regulations.

Compliance, particularly in the medical devices sector, is non-negotiable as failures could literally put lives at risk. In the past year, firms across Europe have been coming to terms with the EU Medical Device Directive (MDD) after an initially shaky start. Some firms questioned that lack of guidance offered to accompany the new regulations, but now those questions have been answered, many have to get down to the difficult task of making the changes required to ensure that existing products comply with the new rules, and to alter processes and designs so that new device manufacturing and software will also pass the test.

Speaking to MDDI Online, Leonard Eisner, of Eisner Safety Consultants, said that this is a long process and one that businesses should not shy away from, explaining that there is much to be done between now and when the regulations come into force in June 2012. However, he suggested that the problems that the regulations cause software companies could help a drive towards innovation.


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The 2nd Annual Software Design for Medical Devices Europe event will be hosted from 31st January – 2nd February, 2012. For more details, visit the Software Design for Medical Devices website, call freephone: 0207 036 1300 or email: enquire@iqpc.co.uk.