Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

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The goal of medical device software development should be to select a process and architecture that ensure a safe and effective product. The methods utilized to achieve this goal differ among medical ...

Regulated healthcare companies are under increasing pressure to move faster while maintaining the highest standards of ...

Medical software is the backbone of modern healthcare, supporting electronic health records (EHRs), diagnostic systems, imaging technologies and embedded software in medical devices like pacemakers ...

Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices ...

This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision ...