# How to Speed Up Safety Critical Processes

- Show: [The Pragmatic Embedded Podcast](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast)
- Published: 2021-07-27
- Length: 33m
- Page: https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-07-27-how-to-speed-up-safety-critical-processes
- Listen: https://agileembeddedpodcast.com/episodes/how-to-speed-up-safety-critical-processes-dxHoiqXd

## Summary

Jeff Gable and Luca Njani discuss strategies to accelerate safety-critical development in medical devices, automotive, and aerospace without compromising quality. They argue that reducing scope for initial releases and automating documentation using modern tools like Jama and Matrix significantly shortens cycle times. The hosts emphasize that modern regulatory guidance, such as the FDA's Computer System Assurance, supports streamlined validation processes, allowing teams to iterate faster and uncover defects earlier.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-07-27-how-to-speed-up-safety-critical-processes#t=0) Introduction: Jeff Gable and Luca Njani on Speeding Safety Critical Processes
- [1:29](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-07-27-how-to-speed-up-safety-critical-processes#t=89) The Business and Engineering Case for Faster Iteration
- [6:48](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-07-27-how-to-speed-up-safety-critical-processes#t=408) Defining Safety Critical Requirements and Regulatory Burdens
- [12:19](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-07-27-how-to-speed-up-safety-critical-processes#t=739) Minimizing Scope and Leveraging 510(k) Deltas
- [14:11](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-07-27-how-to-speed-up-safety-critical-processes#t=851) Automating Documentation with Jama and Matrix
- [22:56](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-07-27-how-to-speed-up-safety-critical-processes#t=1376) Challenges with Tool Validation and FDA Guidance
- [29:55](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-07-27-how-to-speed-up-safety-critical-processes#t=1795) Conclusion and Resources

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Embedded firmware](https://hardwarepodcasts.com/topic/embedded-firmware)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Jeff Gable (other)
- Luca Njani (other)
- FDA (other)
- Jama (other)
- Matrix (other)
- DOORS (other)
- Bluefruit software (company)
- Gene Kim (other)
- The Devops Handbook (other)

## Related episodes from other shows

- [67: Software for Things That Can Kill People](https://hardwarepodcasts.com/podcast/embedded-fm/2014-09-11-67-software-for-things-that-can-kill-people) (Embedded.fm)
- [The Future of Cybersecurity](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-30-the-future-of-cybersecurity) (Global Medical Device Podcast)
- [#326 CSA vs. CSV: Modern Validation for Modern MedTech](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-07-326-csa-vs-csv-modern-validation-for-modern-medtech) (Global Medical Device Podcast)
- [#335: Accelerating SaMD Development in a Compliant Agile way](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-09-08-335-accelerating-samd-development-in-a-compliant-agile-way) (Global Medical Device Podcast)
- [#407: Cybersecurity in MedTech: FDA Compliance, Patient Safety & the Hidden Risks You’re Missing](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-05-19-407-cybersecurity-in-medtech-fda-compliance-patient-safety-the-hidden-risks-your) (Global Medical Device Podcast)

## Citing this page

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