Quality Management System
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How to create a QMS compliant to MDR with Stefan Bolleininger
MDR is requiring to create a Quality Management System but how to do that. This is what you will learn with Monir El Azzouzi and Stefan Bolleininger.
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Medical Device School: How to audit your Suppliers?
How should you audit your suppliers? Should you do the same as a Notified Body? Monir El Azzouzi and Stefan Bolleininger are providing you their opinion.
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Medical Device School: Product Development or Documentation creation?
When you are trying to create your product there is one question that you should answer: Should you focus on your product development or your documentation creation? Listen to our argument on this episode of the podcast.
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How to validate an eQMS with Jacob Sjorslev
After episode 47 on how to implement an eQMS, Jacob Sjorslev is now telling us how to validate an eQMS. This is something mandatory now since ISO 13485:2016. So listen carefully and download the giveaway,
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How to implement an eQMS with Jacob Sjorslev
An eQMS can be a necessary tool for your Quality Management System. This is why it's implementation should be executed as a project. Jacob Sjorslev will be your instructor and tell what to do and what to avoid. And Jacob will also make you an offer at the end of the episode.
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Medical Device School – Most important issues on your CAPA (ISO 13485)
On the Medical Device School segment, we will help you understand how to be better with your CAPA system. Stefan Bolleininger and Monir El Azzouzi are sharing with you their experience.
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Episode 35 – Digitalization of QA RA with Michael Kania
Digitalization of QA RA is a concept that many Medical Company didn't adopt. But what can they win if they engage on it? This is the topic of today´s episode.
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Episode 29 – 5 Steps to create a QMS with Jason Lim
Jason Lim will reveal to us what are the 5 steps to create a good Quality Management System or QMS.
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Episode 17 – Unannounced audit stories with Florent Guyon
On this new Episode, Florent Guyon from Nexialist is sharing with us his anecdotes regarding unannounced audit. He will also talk to us about a Master Degree he proposes at the ISIFC Biomedical Engineering School
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Episode 12 – How to create an ISO Standard with Marcelo Antunes
Marcelo Antunes from SQR Consulting is walking us through the process of Standard creation. You'll understand how you can participate to it and why it is so important. We will also discuss about the Elsmar Cove Forum that is a great source of support.
