Medical Device made Easy Podcast

Jason Lim will reveal to us what are the 5 steps to create a good Quality Management System or QMS. The post Episode 29 – 5 Steps to create a QMS with Jason Lim appeared first on Medical Device made Easy Podcast . Monir El Azzouzi

How an OEM or Original Equipment Manufacturer can help the OBL (Own Brand Labeller) to continue business? Stefan Bolleininger from Be-On-Quality will help us on this second part of the Podcast. The post Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2 appeared first on Medical Device made Easy Podcast . Monir El Azzouzi

The OEM and OBL model is under question with the new EU MDR and IVDR regulations. Stefan Bolleininger will help us understand how to continue to be compliant and continue business. The post Episode 27 – OEM & OBL Model with Stefan Bolleininger [Part 1] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi

Andreas Stange from TÜV SÜD will help us be prepared for the new IVDR or In-Vitro Diagnostic Regulation. This is a game changer for the manufacturers as more products are on the scope of a notified Body certification. The post Episode 26 – IVDR preparation with Andreas Stange appeared first on Medical Device made Easy Podcast . Monir El Azzouzi

EUDAMED is the new European Database for Medical Devices and this is something that can change completely the world of Medical Devices. For the consumers and the manufacturers. The post Episode 25 – EUDAMED secrets with Richard Houlihan appeared first on Medical Device made Easy Podcast . Monir El Azzouzi

Are you hiring contractors or consultants for your projects? Do you know the difference or do you know what are the myths about them? Thomas McMann from EPM Scientific is sharing that with us. The post Episode 24 – Myths about consultants with Thomas McMann appeared first on Medical Device made Easy Podcast . Monir El Azzouzi

Alethea Wieland, President of Clinical Research Strategies will tell us what are the most important criteria to select a good CRO for your clinical trial project. The post Episode 23- TOP 10 criteria to select a CRO with Alethea Wieland appeared first on Medical Device made Easy Podcast . Monir El Azzouzi

What is a Clinical Trial or Clinical Investigation? And should a Medical Device Company start a Clinical Trial or perform a Clinical Evaluation? I invited Alethea Wieland from Clinical Research Strategies to help us have a better understanding. She will help beginners in this area to learn about the fundamentals of clinical trials. The post Episode 22 – Clinical Trial with Alethea Wieland ap...

For those that want to work on a Regulatory Affairs department, the path can be difficult. We are looking for people that are experimented but before to be experimented they should start somewhere. So how to do that? Samantha Alsbury from TOPRA will help us on this new episode. The post Episode 21 – How to master Regulatory Affairs with Samantha Alsbury appeared first on Medical Device made...

Blockchain for Healthcare is a new Technology. On this episode, Khuram Malik will tell us what is Blockchain and how Medical Devices can use it. The post Episode 20 – What is a Blockchain with Khuram Malik appeared first on Medical Device made Easy Podcast . Monir El Azzouzi

Cyrille Michaud from MD101 Consulting is helping us to understand the new rule 11 to classify Software Devices in the European Union. This is a new rule so this creates a lot of discussion in the industry. Let's clarify that with Cyrille. The post Episode 19 – Rule 11 for Software Devices with Cyrille Michaud appeared first on Medical Device made Easy Podcast . Monir El Azzouzi

Is it the right moment to move to another position if you are in Quality and Regulatory affairs? Petra Ognjenovic from SciPro Global is helping us to decode the situation on the recruitment market. She will also provide us some tips to find the right candidate. The post Episode 18 – QA RA Recruitment situation with Petra Ognjenovic appeared first on Medical Device made Easy Podcast . Monir E...

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 The post Episode 17 – Unannounced audit stories with Florent Guyon appeared first on Medical Device made Easy Podcast . Monir El Azzouzi

Sean Hamilton from War on Epilepsy is a Seanpreneur as he says on this episode. He is epileptic and this made him think that he can maybe create a Medical Device for people with the same condition. So he founded War On Epilepsy. Listen to his story which provides a great message. The post Episode 16 – From Disease to a Medical Device with Sean Hamilton appeared first on Medical Device made E...

On this second part of the podcast episode, Erik Vollebregt is continuing to tell us more stories on the background of the MDR and IVDR. We'll discuss about the differences between big and small companies and also the brexit, notified bodies and finally rule 11 for the classification of Software The post Episode 15 – MDR & IVDR discussion with Erik Vollebregt Part 2 appeared first on Me...

Erik Vollebregt from Axon Lawyer is explaining to us what is the EU MDR and IVDR. This will be a 2 part episode with a lot of anecdotes. Erik is also the author of the blog MedicalDevicesLegal.com The post Episode 14 – MDR & IVDR stories with Erik Vollebregt (Part 1) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi

Richard Young from Sensus group talk to us about the Brexit Situation. His company is located in the UK and is helping Medical Device manufacturers to overcome this situation. Brexit date is planned on March 29th, 2019 and for now there is no deal reached. The post Episode 13 – Brexit Talk with Richard Young appeared first on Medical Device made Easy Podcast . Monir El Azzouzi

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. The post Episode 12 – How to create an ISO Standard with Marcelo Antunes appeared first on Medical Device made Easy Podcast . Monir El Azzouzi

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. The post Episode 11 – Medical Device Software Validation appeared first on Medical Device made Easy Podcast . Monir El Azzouzi

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 […] The post Episode 10 – Understand MDSAP with Angelina Hakim appeared first on Medical Device made Easy Podcast . Monir El Azzouzi

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 […] The post Episode 9 – Entrepreneurial journey with Ivan Perez Chamorro appeared first on Medical Device made Easy Podcast . Monir El Azzouzi

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. The post Episode 8 – From Correction to Prevention with ODIAC appeared first on Medical Device made Easy Podcast . Monir El Azzouzi

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 […] The post Episode 7 – Make your KPIs Green again appeared first on Medical Device made Easy Podcast . Monir El Azzouzi

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. The post Episode 6 – What are the 6 types of Medical Device Audits appeared first on Medical Devi...

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. The post Episode 5 – Medtech P...