The topic of Promotional Compliance is really important in the USA. As you will hear on this episode, advertisement is everywhere and most importantly, the advertisement for Healthcare Products. The post Episode 30 – Promotional Compliance with Darshan Kulkarni appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
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 appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
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 Easy Podcast . Monir El Azzouzi...
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 El Azzouzi...
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 Easy Podcast . Monir El Azzouzi...
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 Medical Device made Easy Podcast . Monir El Azzouzi...
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 Device made Easy Podcast . Monir El Azzouzi...
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 Prediction 2019 appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
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. The post Episode 4 – UDI for Unique Device Identification appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
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. The post Episode 3 – Is my Product a Medical Device in Europe? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
The new EU Medical Device Regulation MDR 2017/745 will be in place by May 26th, 2020 but are you already aware of its content. Listen to this episode to know more. I provide you some information the timeline for the application of the MDR and also the changes that happen. On the resources, I link to a blog post I created on this topic. And as a gift, I propose you to download an Alexa Skill to tell you how many days remains until the new Medical Device Regulation is live. The post Episode 2 R...
Within this first episode of the Medical Device made Easy Podcast I am introducing myself and also this podcast. Don´t forget to subscribe to it so you can be notified when a new episode is released. The post Episode 1 – Introduction to the Medical Device made Easy Podcast appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
