# Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-12-23
- Length: 42m
- Episode: 173
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-23-post-pandemic-readiness-preparing-for-the-aftermath-of-covid-19-on-the-medical-d
- Listen: https://podcast.greenlight.guru/episode/post-pandemic-readiness-preparing-for-the-aftermath-of-covid-19-on-the-medical-device-industry

## Summary

Steven Niedelman and Eric Henry from King & Spalding discuss post-pandemic readiness for the medical device industry, focusing on the transition from Emergency Use Authorizations (EUAs) to full regulatory compliance. They explain the current state of FDA inspections, the role of the Medical Device Single Audit Program (MDSAP), and the critical need for companies to build or remediate Quality Management Systems (QMS) before EUAs are revoked. The guests advise on preparing for pre-submission meetings with the FDA and managing the logistical challenges of a massive influx of regulatory submissions.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-23-post-pandemic-readiness-preparing-for-the-aftermath-of-covid-19-on-the-medical-d#t=0) Introduction and Guest Backgrounds
- [4:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-23-post-pandemic-readiness-preparing-for-the-aftermath-of-covid-19-on-the-medical-d#t=282) FDA Inspection Paradigm and Virtual Audits
- [7:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-23-post-pandemic-readiness-preparing-for-the-aftermath-of-covid-19-on-the-medical-d#t=444) MDSAP and Remote Audit Acceptance
- [11:43](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-23-post-pandemic-readiness-preparing-for-the-aftermath-of-covid-19-on-the-medical-d#t=703) Impact of EUAs and 564A Authorizations
- [17:13](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-23-post-pandemic-readiness-preparing-for-the-aftermath-of-covid-19-on-the-medical-d#t=1033) QMS Remediation and Inspection Preparation
- [28:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-23-post-pandemic-readiness-preparing-for-the-aftermath-of-covid-19-on-the-medical-d#t=1690) Pre-Submission Meetings and FDA Communication
- [37:26](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-23-post-pandemic-readiness-preparing-for-the-aftermath-of-covid-19-on-the-medical-d#t=2246) Staffing Needs and Mock Inspections

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Hiring & workforce](https://hardwarepodcasts.com/topic/hiring-and-workforce)

## Most relevant to

companies scaling up

## Mentioned

- King & Spalding (company)
- FDA (company)
- MDSAP (other)
- Green Light Guru (company)
- 21 CFR Part 820 (other)
- ISO 13485 (other)
- EU MDR (other)
- 510(k) (other)
- PMA (other)

## Related episodes from other shows

- [256 - The New FDA Inspection Playbook: Where to Start with QMSR](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-28-256-the-new-fda-inspection-playbook-where-to-start-with-qmsr) (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)
- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (Let's Combinate)
- [128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t) (Let's Combinate)
- [198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-23-198-qmsr-explained-iso-13485-compared-and-5-key-things-you-mightve-missed) (Let's Combinate)

## 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/2020-12-23-post-pandemic-readiness-preparing-for-the-aftermath-of-covid-19-on-the-medical-d. 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.