# Common QMS Mistakes SaMD Companies Make

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-10-21
- Length: 45m
- Episode: 285
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-21-common-qms-mistakes-samd-companies-make
- Listen: https://podcast.greenlight.guru/episode/common-qms-mistakes-samd-companies-make

## Summary

Karandeep Singh Badwal, founder of QRA Medical, explains common Quality Management System (QMS) mistakes made by Software as a Medical Device (SaMD) companies, emphasizing that validation must cover all software used in the QMS, not just the device itself. He highlights the frequent failure to treat cloud platforms and software tools like Trello or AWS as controlled suppliers, and the oversight of patient data as customer property. Badwal also stresses the importance of defining deputy roles for key personnel and tailoring procedures to specific jurisdictions like EU MDR and UK regulations.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-21-common-qms-mistakes-samd-companies-make#t=0) Introduction: Karandeep Singh Badwal and QRA Medical
- [2:47](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-21-common-qms-mistakes-samd-companies-make#t=167) Defining Quality Management Systems and Forms
- [5:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-21-common-qms-mistakes-samd-companies-make#t=324) SaMD Software Validation Scope and Evidence
- [12:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-21-common-qms-mistakes-samd-companies-make#t=769) Validating Training Programs and Effectiveness
- [14:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-21-common-qms-mistakes-samd-companies-make#t=864) Customer Property and Physical Components in SaMD
- [22:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-21-common-qms-mistakes-samd-companies-make#t=1327) Supplier Evaluation and Software as Suppliers
- [28:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-21-common-qms-mistakes-samd-companies-make#t=1709) Risk-Based Approach and ALARP vs As Far As Possible
- [32:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-21-common-qms-mistakes-samd-companies-make#t=1954) Internal Audits and Independent Reviewers
- [35:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-21-common-qms-mistakes-samd-companies-make#t=2105) Jurisdictional Standards: EN, BS-EN, and Reporting Deadlines
- [40:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-21-common-qms-mistakes-samd-companies-make#t=2433) Handling Unannounced Audits and QMS Implementation Timing

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies

## Mentioned

- QRA Medical (company)
- Greenlight Guru (company)
- ISO 13485 (other)
- EU MDR (other)
- Trello (product)
- Amazon AWS (product)
- BSI (company)
- UK MDR (other)

## 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)
- [090 - Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-21-090-software-validation-automation-no-code-quality-tools-and-qms-with-harsh-thak) (Let's Combinate)
- [S1E12 Simplifying Quality Management | Jon Speer](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer) (Being an Engineer)
- [155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-25-155-fda-compliance-programs-program-7536-000-cder-vs-cdrh-led-inspections-mock-p) (Let's Combinate)
- [S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements) (Being an Engineer)

## 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/2022-10-21-common-qms-mistakes-samd-companies-make. 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.