A report based on Healthcare IQ's recent survey of OEMs to discover how those working in software design for medical devices were using Agile and other methodologies. Those survey responses are shown here along with the notes of an industry insider with 20 years experience in the field.
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The only truly international forum dedicated to medical device software standards, regulatory compliance and development
Being truly agile in such a regulated environment is a challenge, and manufacturers constantly seek to improve the quality, usability and software lifecycle of their device development.
SDMD is the only truly international forum dedicated to medical device software development & compliance, and as of 2013 is now a complete one-stop-shop for all RA/QA and Software Engineers involved in medical device development.
With a new, in-depth look into compliance and quality issues, as well as the usual popular topics of agile programming methods, new testing/V&V techniques and product usability, international medical device company QA-RA and software professionals have a real must-attend date in the calendar - the only truly international and English-language software development and compliance forum dedicated to medical devices.
You missed 2014?
Or just want a recap? Here are the top 3 discussion points from the 2014 chair's summary, Chuck Sidebottom, former Director of Corporate Standards, Medtronic;
- The evolving European medical device regulation that is targeted to replace the current medical device and active implantable medical device directives
- The regulatory and compliance track was how the outputs, in particular the documentation, produced by the Agile methodology can fulfill the requirements of the quality system required of almost all medical device manufacturers
- The interface between the software requirements and the usability of the medical device of which the software was a part
We hope to see you in 2015 to carry on the discussion!