What is software risk management in safety-critical domains?

In the Medical Device market, safety is defined as freedom from unacceptable risk. Even regulatory agencies acknowledge that there is no such thing as a risk-free medical device. Medical device manufacturers have to aim for safer medical devices which, in turn, result in fewer device recalls. Risk Management is the process by which software risks […]

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The worlds of software development and medical devices could not be further apart

Software development is agile, fast and innovative, while medical device development is often slow, reactive and change adverse. SoftComply has developed a set of tools which will help your company comply with the regulatory requirements with the minimum effort and get your innovative medical devices to market faster. Numerous software companies struggle to enter medical […]

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