February 2021 Update – Medical Devices Remote Audit by the EU

Medical Device made Easy Podcast · Feb 2, 2021

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In this monthly episode of the podcast, we do a regulatory intelligence review of what happened monthly.

The agenda for this month is:

Countdown until EU MDR by Michelle Lott (LeanRAQA)

Remote Audit authorized for EU MDR

SURVEY Result

US update on Recognised Consensus Standards

Canada guidance on Vigilance Reporting

Training available

Notified Body Situation

UK Approved Body

Guidance and Standards

PODCAST and LIVE episodes

Look at all the links below.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

After working for…