What is software as a medical device (SaMD)? How does one test SaMD? What testing is required? What are the risks related to your SaMD and its testing?

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Rahul Kallampunathil, Vice President of Arbour Group’s Digital Compliance practice, about digitizing your SaMD testing.

Rahul builds teams that help companies proactively manage compliance risks toward a true digital enterprise. He is an innovative thinker with more than 18 years of experience in risk management, compliance, and internal controls focused on information technology and data.

Some of the highlights of this episode include:

Rahul defines SaMD as software used to perform a medical purpose without being part of a hardware medical device. SaMD is capable of running on any general purpose platform, such as your Android or iOS mobile phone.
SaMD is different from software in a medical device (SiMD). SaMD is independent from hardware; SiMD is embedded in a physical medical device.
Also, there’s differences between SaMD and medical device data systems (MDDS). MDDS only transfers, stores, or displays medical device data, but it does not have an algorithm or business rule to help make medical decisions.
IEC 62304 impacts SaMD organizations and how they approach the risk of their solution. All SaMDs are not equal, and it’s important to understand the level of risk in every SaMD.
Companies should prepare for SaMD testing with a clinical evaluation to demonstrate a valid clinical association between SaMD’s output and targeted clinical condition.
Before thinking about designing and developing a product, a quality management system (QMS) should be established. Software companies need to adopt and modify their QMS to serve their product and its users, while fulfilling FDA requirements.
Rahul discusses the pros and cons of manual versus automated/electronic documentation and testing, including risk management for patient safety.
Best practices for SaMD testing are using agile and devops methodologies. Potential pitfalls are not testing continuously, even after the product is on the market.

Memorable quotes from Rahul Kallampunathil:

“Software as a medical device - it is software that is intended to be used for a medical purpose, and it performs that purpose without being part of a hardware medical device.”

“There is no physical device, in this case, that you can touch and feel. It’s purely software.”

“The nature of software - it’s something that you cannot touch or see. It’s all code. From a testing perspective, especially, there’s a lot of things that you need to pay attention to.”

“The quality management system or quality management process, that has to be established even before you think about the product, even before you design the product.”

Links:

Rahul Kallampunathil on LinkedIn

Etienne Nichols on LinkedIn

Arbour Group LLC

FDA - SaMD

FDA - Medical Device Data Systems (MDDS)

Digitizing your SaMD Testing

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