# Digitizing your SaMD Testing

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-08-03
- Length: 51m
- Episode: 274
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-03-digitizing-your-samd-testing
- Listen: https://podcast.greenlight.guru/episode/digitizing-your-samd-testing

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-03-digitizing-your-samd-testing#t=0) Introduction and SaMD Definitions
- [4:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-03-digitizing-your-samd-testing#t=241) Distinguishing SaMD, SiMD, and MDDS
- [10:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-03-digitizing-your-samd-testing#t=632) Regulatory Pathways and IEC 62304
- [15:57](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-03-digitizing-your-samd-testing#t=957) Establishing Quality Management Systems
- [25:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-03-digitizing-your-samd-testing#t=1533) Agile, DevOps, and Automated Testing
- [29:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-03-digitizing-your-samd-testing#t=1742) Computer Software Assurance vs. Validation
- [38:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-03-digitizing-your-samd-testing#t=2328) Post-Market Surveillance and Cybersecurity

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Security & privacy](https://hardwarepodcasts.com/topic/security-and-privacy)

## Most relevant to

early-stage companies

## Mentioned

- Arbour Group (company)
- Green Light Guru (company)
- FDA (company)
- IEC 62304 (other)
- IMDRF (company)
- Android (product)
- iOS (product)
- NIST (company)

## Related episodes from other shows

- [021 - "Options" with Karandeep Singh Badwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal) (Let's Combinate)
- [134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-01-134-iso62304-software-development-process-samd-closed-loop-systems-complexities) (Let's Combinate)
- [Living Documentation and Test Automation with Paul Massey](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-07-15-living-documentation-and-test-automation-with-paul-massey) (The Pragmatic Embedded Podcast)
- [Rapid Prototyping for Medical Devices with Ross Dehmoobed](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-01-11-rapid-prototyping-for-medical-devices-with-ross-dehmoobed) (The Pragmatic Embedded Podcast)
- [How to Speed Up Safety Critical Processes](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-07-27-how-to-speed-up-safety-critical-processes) (The Pragmatic Embedded Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-03-digitizing-your-samd-testing. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.