By Marion Lepmets, CEO of SoftComply* & Tom Stamp, CEO of Blue Curve** Following our article from last week on “Is My Software a Medical Device” to those of you who are now convinced that your software is indeed a duck (see the original article), then you are probably wondering “How do I get it […]
What is Software as a Medical Device?
By Marion Lepmets, CEO of SoftComply* & Tom Stamp, CEO of Blue Curve** If it looks like a duck, swims like a duck, and quacks like a duck, then it’s probably a duck… or a medical device! Medical devices can be purely hardware based (eg stethoscopes), be composed of hardware and software (eg patient monitor) […]
Cloud-Based SaaS Tools & Software Validation Compliant with Medical Device Regulations
The continued rise in the use of cloud-based and SaaS (software as a service) tools adds further challenges to the already complex domain of medical device software development that needs to adhere to regulations. How can medical device software developers and healthcare providers benefit from cloud computing while being compliant with regulations that require full control over the software […]
An Overview of Medical Device Software Regulations – International Standards and FDA Guidance Documents
Medical Device Software Safety Safety is the central concern for medical device software development. 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 […]
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 […]
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 […]
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 […]
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 […]
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 […]