Recent Posts
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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.
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Episode 11 – Medical Device Software Validation
Bill Stamm and Rafael Blanco from General Digital Software Services are helping us to understand Medical Device Software Validation. This process is becoming more and more important as the Healthcare business is transitioning to digitization.
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Episode 10 – Understand MDSAP with Angelina Hakim
On today’s show, I invited Angelina Hakim the CEO of Qunique which is an Agency helping customers on Regulatory projects and also provide some service as an auditor. She has […]
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Episode 9 – Entrepreneurial journey with Ivan Perez Chamorro
Show Notes This episode of the Medical Device made Easy Podcast is special as this is the first one I am doing with a guest. I have interviewed Ivan Perez […]
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Episode 8 – From Correction to Prevention with ODIAC
Learn one of the many methods to move your working area from Correction to Prevention with the ODIAC method. Don't try to find it on Google because I created it only for you. Learn how to solve issues before they come to your desk.
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Episode 7 – Make your KPIs Green again
KPIs means Key Performance Indicators. This is an important part of the Quality Management System of a company. This is not specific to Medical Devices but you have to have […]
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Episode 6 – What are the 6 types of Medical Device Audits
On this episode of the Medical Device made Easy Podcast I will tell you what are the 6 Types of Medical Device Audits. I know that when you are talking about audit on your companies, there are some kind of Panic Mode. Or maybe you are more "Always Audit ready". So listen to learn more on audits.
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Episode 5 – Medtech Prediction 2019
2019 is here and as I read many media´s predictions for the medtech industry, I decided to also predicte myself what will be a trend. I will talk specifically about 2 axes which are Technologies and Regulations. Both are linked because as regulators we need to understand the technologies to be able to provide the right answer when we need to issue a regulation.
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Episode 4 – UDI for Unique Device Identification
UDI for Unique Device Identification. You will need to understand what is happening with the UDI to be able to implement it. So let´s learn first about the vocabulary.
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Episode 3 – Is my Product a Medical Device in Europe?
Medical Device made Easy Podcast Episode 3- On this episode I help you to define if your product is a Medical Device in Europe? I know it sounds basic but you´ll see that the new Medical Device Regulation MDR 2017/745 is changing the rules. So listen carefully.
