Quality Management System
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Why is it great for Importers to be ISO 13485 certified? [Cristina Miroescu]
We may think that ISO 13485 certification is only for Medical Device manufacturers but in this episode you will hear Cristina Miroescu from Sofmedica Group tell us why its company decided to be certified even if they are not manufacturing devices.
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Let’s introduce you to our eQMS SmartEye with Anindya Mookerjea
We have worked since more than a year on an eQMS called SmartEye and I have invited Anindya Mookerjea the CEO of SCube Technologies to present the tool and talk about the advantages of electronic Quality Management Systems.
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Training Process – What are the mistakes to avoid? [ISO 13485]
Great episode with Rod and Katie on Training Requirements. A lot of afvices that can help you pass audits and remain compliant
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How to be great at Management Reviews? [ISO 13485]
Management Review is one of the most important activity to perform before to be ISO 13485 certified. So today I will explain to you how to be great at it.
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How a Quality & Regulatory training can help you? [Sofmedica]
In this episode, we will tell you why this is important to invest on trainings for your employees. I have invited a company that participated to the Green Belt Certificate and I asked them to tell us what they have implemented after taking this training.
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How to perform your Process Validation with Adnan Ashfaq (IQ OQ PQ)
Process Validation is an important but difficult topic. You should not only be good at engineering but also at explaining to your staff. Because a good validation worth nothing if the Staff is not following the instruction. Listen to Monir El Azzouzi and Adnan Ashfaq sharing with you their experience.
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How to execute your Internal Audits? (Medical Device companies)
In this episode, I will help you understand the power of Internal Audits. Some of you are using that just because ISO is requiring it but you can get so much out of it.
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How to get ISO 13485 certified? (Quality Management System)
I'll answer one of the most frequently asked question I receive from my followers. How to get ISO 13485 certified? Don't miss the links on the show notes to get more material to read.
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Do your Economic Operators need a Quality Management System?
It is clear that a Manufacture of a Medical Device need to have a Quality Management System. But what is the answer for an importer, Distributor or Authorized Representative? You'll hear it on this episode where Erik Vollebregt will help us understand the requirements of the regulation.
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Medical Device School – Process Validation or Verification?
Process Validation or Verification? Some people are mixing both concepts, this is why Monir and Stefan will help you understand when to use one or the other.
