skip to Main Content
Aligning Agile Practices

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.

Related Resources

Peace of Mind At Your Fingertips: Digital Health Funding Explodes

To say that the Covid-19 pandemic has changed our lives is a major understatement. Since the outbreak, we’ve all experienced fear, anxiety and some form of loss. We’ve also found new ways to appreciate life,…

READ MORE

Align Agile Practices with QMS Requirements

By Allen Chen, Senior Quality Engineer at Rook Quality Systems Taiwan Branch Agile is a practical framework and an iterative approach for product development and project management. With the rise of the internet of things…

READ MORE

Five action items to address Artificial Intelligence/Machine Learning- based SaMD

The FDA recently released an Action Plan to address Artificial Intelligence/Machine Learning (AI/ML)-based Software as a Medical Device (SaMD). The action plan is based on efforts by the FDA in the last two years in…

READ MORE
Related Tools & Templates
Subscribe to our Newsletter
Join our mailing list for the latest Rook events, thought leadership, and more.
Back To Top