Struggling with risk traceability in your safety critical product designs?

Coming up: the SoftComply Risk Manager! In most safety-critical product development projects, the product has to receive external agency approval and/or pass an audit prior to release to market. One of the aims of such an approval is to check whether the product is safe to use. In order to demonstrate this, it is usually […]

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Medical Device Software – it’s CLASSIFIED!

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 […]

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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) […]

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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 […]

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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 […]

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