Hardware Podcasts

Digitizing your SaMD Testing

Global Medical Device Podcast · 3 Aug 2022 · 51m · Episode 274

What this episode covers

Rahul Kallampunathil, Vice President of Arbour Group’s Digital Compliance practice, explains the regulatory and testing requirements for Software as a Medical Device (SaMD). He distinguishes SaMD from Software in a Medical Device (SiMD) and Medical Device Data Systems (MDDS), noting that SaMD requires a full regulatory pathway while MDDS is often Class I. Kallampunathil advocates for adopting agile and DevOps methodologies with automated testing to manage the rapid iteration cycles of SaMD, contrasting this with traditional Computer Software Validation (CSV) in favor of Computer Software Assurance (CSA). He emphasizes that quality management systems must be established before product design and that post-market surveillance, including cybersecurity and platform compatibility, is critical for SaMD success.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Arbour Group, Green Light Guru, FDA, IMDRF, NIST
Products
Android, iOS
Also
IEC 62304

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