Software as a Medical Device Regulation Support

Aligning Agile Practices

RookQS’ dedicated software quality team provides validation and testing strategies and support for software, including SaMD, SiMD, apps, AI/ML 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.

What is Software as a Medical Device (SaMD)?

SaMD is a standalone software that performs one or more medical purposes without being a part of a hardware device. Software as a medical device can range from pulse oximeter to an MRI machine. SaMD is commonly programmed using the Agile Model which is very versatile and adaptive. From a quality perspective we capture the high level documentation of SaMD with software design plans, deployment plans, and wireframes, etc. Rook can walk you and your team of software engineers through all the required documents ranging from classifying your softwares risk class to user requirement specifications.

Examples of software that may be considered a medical device include:

• Electronic health records (EHR) systems
• Computerized physician order entry (CPOE) systems
• Clinical decision support systems (CDSS)
• Electronic prescribing systems
• Medical imaging software
• Patient monitoring systems
• Laboratory information management systems (LIMS)
• Diagnostic test interpretation software
• Genetic analysis software
• Telemedicine platforms

More and more software as a medical device (SaMD) manufacturers are beginning to leverage agile practices to develop software products 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.

SaMD, Artificial Intelligence, & Machine Learning (AI/ML)

Artificial Intelligence is an expanding field in the software realm. With new regulations coming surrounding AI. These guidance documents that are being released are currently assessing the pathway for software that automatically updates without supervision. If you are looking for regulatory guidance for your AI medical device. Look to Rook for Answers.