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 […]
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 […]
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 […]