Similarities and Conflicts Between Agile and Safety-Critical Software Developers

In the last two weeks, SoftComply went to the Atlassian Summit and to the Advamed Conference. Both, the software conference and the medical device conference were huge in their number of attendees as well as in the number of parallel sessions with interesting talks and wonderful networking opportunities. Yet, it would be hard to find […]

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Is Europe More Innovative Than the US?

  Europe has a more distributed approval system which has resulted in medical devices being approved and made available in Europe three to four years before these devices are approved in the US1. Even if Europe provides a faster route to market for medical device products, it has not affected their safety, i.e. there is […]

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Building Medical Software Compliance on Atlassian Tools

What is Atlassian Summit? The biggest annual event of Atlassian will take place next week with hundreds of Atlassian users and developers descending to San Jose to listen to the success story of one of the fastest growing enterprise software technologies today. Their high-velocity distribution model drives an exceptional customer scale by making affordable products […]

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Small, Innovative & Compliant: Innovation in Medical Device Domain comes from Small Companies!

A year ago, the panel of medical and academic experts at the US Policy Network’s annual meeting said that the fast-moving medical technology innovations are threatened by established interests and government regulations1 . The challenges of getting innovative medical device products out to market are subject to major regulatory audits that take a lot of […]

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Building regulatory compliance into the software development life cycle

Safety is the central concern for medical device software development and the development of safe systems is rigorously supported by various regulatory requirements focusing on development process compliance. In other words, a strong emphasis is placed on regulatory oversight and device approval before market release to ensure proper verification and validation of these devices. Due […]

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