RookQS’ dedicated software quality team provides validation and testing strategies and support for software, including SaMD, SiMD, apps, and QMS software. Our goal is to ensure Regulatory Compliance with ISO 13485:2016, IEC 62034/82304, and IEC 60601. RookQS has a decade of hands-on experience creating and working in a QMS for software companies.
Developing a software as a medical device (SaMD) requires timely synchronization of software development processes with specific procedures and requirements under a QMS.
And if you intend to implement agile practices in your software development, you may find they seem to contradict the regulated process for developing a medical device. Rook helps emerging medical device companies develop and maintain an effective and efficient quality system, concurrently with active sprint cadence.
More and more software as a medical device (SaMD) manufacturers are beginning to leverage agile practices to develop software to better assist healthcare providers and improve patient outcomes. Agile practice is becoming an eagerly adopted tool for all software development teams to de-risk their projects and further prepare themselves to embrace software change requests in a compliant manner.
RookQS has deep experience around QMS procedures for a SaMD project, and can educate emerging companies on why Software Safety Classification and Level of Concern are so critical, how best to manage SaMD releases and configuration management, and how to ensure good communication among cross functional teams.
The Final Clinical Decision Support (CDS) Guidance, describes the FDA’s regulatory approach to Clinical Decision Support (CDS) software functions. Suffice it to say that much of the previously designated non-device CDS software might no longer…
The trend of the software industry has been evolving throughout the years. In the past, projects were mainly about digitalization, rule based automation, and local server and electronic storage. Today we speak about cloud, serverless…