What to Expect During Medical Device Remote Audits

Published on July 3, 2021

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How do you provide an environment for value-add audits and appraisal activities when your team is working remote? Which factors should you consider for support and execution of your remote audit program? Watch now to learn what your medical device company can expect when faced with a remote audit.

Even with the COVID-19 pandemic, there is still an expectation your organization is in compliance with quality system regulations and standards, including quality audits.

And even as these audits continue, are these activities more, less, or equally as effective?

In this video, George Zack, Principal and Co-Founder at Two Harbors Consulting, discusses what lessons he has learned from recent remote audits and appraisals performed as such specifically because of COVID-19 restrictions.

— Many of the points covered in this discussion are things you’d consider for a normal audit, however, when an audit is remote the logistics, planning, and ultimately, the impact is magnified.

This presentation originally aired during the Greenlight Guru True Quality Virtual Summit, the first and only of its kind with over 30 of the top medical device experts from around the world who presented on top, trending topics segmented into three main focus tracks:

1) GO Track – Covering everything you need to know to get new devices to market with less risk
2) GROW Track – Covering proven best practices for advancing the success of your devices already on the market
3) COVID-19 Track – Covering practical insights into managing and leading medical device companies and teams during the pandemic

The video you’re watching now is from our COVID-19 Track. If you’d like to watch more related videos, browse through the full list of free replays from this track of the True Quality Virtual Summit event: https://www.youtube.com/playlist?list=PLkchw-at8PkNdJqyjakLVnTU8rUJX1qPa

Plus, you can download the slides from this presentation here: https://www.slideshare.net/greenlightguru/remote-audits-in-a-covid19-world

Are you looking for a QMS solution to help you bring safer medical devices to market faster with less risk? Take a quick tour of Greenlight Guru’s Medical Device QMS software: https://www.greenlight.guru/quality-management-software

Like this video? SUBSCRIBE to our channel for more valuable videos on all things medical device! https://www.youtube.com/c/greenlightguru?sub_confirmation=1

#TrueQualityVirtualSummit #MedicalDevice #QMS

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