Medical Device made Easy Podcast
297 episodes - English - Latest episode: 7 days ago - ★★★★★ - 17 ratingsListen Medical Device Regulation and Standards
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Episodes
Medical Device School – Most important issues on your CAPA (ISO 13485)
October 24, 2019 00:00On 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. The post Medical Device School – Most important issues on your CAPA (ISO 13485) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device Disruptions at Hospitals with Stefan Krojer
October 20, 2019 11:01Some signs are raising from Hospitals regarding disruptions on Medical Devices. What is exactly the reason. Stefan Krojer will share with us his experience and a solution he is developing. The post Medical Device Disruptions at Hospitals with Stefan Krojer appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
5 FDA Myths for Start-Ups with Justin Bushko
October 14, 2019 00:00Justin Bushko from Concise Engineering will share with us 5 FDA Myths that exist on the Start-up world. Medical Devices Start-Ups should satisfy Investors and Regulatory, and this can create some strange assumptions. Let'S listen to that. The post 5 FDA Myths for Start-Ups with Justin Bushko appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
GDPR & MDR for Medical Applications with Jovan Stevovic
October 06, 2019 22:38GDPR is also important for the MDR regulation. As we are developing Medical Device application, we should also implement GDPR on our development. Jovan Stevovic from Chino.io will help us understand what it means. The post GDPR & MDR for Medical Applications with Jovan Stevovic appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Register your Medical Device in the US with Michelle Lott (FDA)
September 29, 2019 22:59There are many ways to register a Medical Device in the USA and I propose you to listen to Michelle Lott that will tell you the basics of the FDA regulations. The post Register your Medical Device in the US with Michelle Lott (FDA) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
New rules for the In-Vitro Diagnostic Industry with Maurizio Suppo
September 21, 2019 23:01In-Vitro Diagnostic Regulation will come later and we have time. Maurizio Suppo do have another opinion and as he is really passionate about this topic he will be providing some golden advice that you should not miss. Even for non-IVD manufacturers as we will talk about a proposal if manufacturers cannot meet the deadline. The post New rules for the In-Vitro Diagnostic Industry with Maurizio Suppo appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Learn Post Market Surveillance with Natasha Bankowski
September 15, 2019 23:02On this episode I invited Natasha Bankowski that is also called the PMS Queen to help us understand the Post Marketing Surveillance for Medical Devices. You can also meet her at TOPRA Symposium 2019. The post Learn Post Market Surveillance with Natasha Bankowski appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Product Equivalence for Clinical Evaluation Report (CER) with Helene Quie
September 07, 2019 23:10This episode with Helene Quie from Qmed Consulting contains Diamond of Information. If you are lost regarding Product Equivalence for your CER, then you need to listen that and it will be clearer. The post Product Equivalence for Clinical Evaluation Report (CER) with Helene Quie appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Episode 39 – Networking at Medical Device events with Lynda Wight
September 01, 2019 22:30Networking at events can be a great experience or a disaster. On this episode we will help you to be prepared for it. We will use the TOPRA symposium as an example. The post Episode 39 – Networking at Medical Device events with Lynda Wight appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Episode 38 – Be the Best Candidate Ever with Mitch Robbins
August 26, 2019 00:00How can you be considered the best candidate ever? This is what will be presented today by Mitch Robbins from the Anthony Michael Group. And learn also why he called his company with this name. The post Episode 38 – Be the Best Candidate Ever with Mitch Robbins appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Episode 37 – Usability & Human Factor with Sharon Ayd
August 19, 2019 00:00Let's not talk about theory but really about experience when we are looking for Usability tests and Human Factors. Sharon Ayd will share with us a project where she was able to use these notions to succeed. The post Episode 37 – Usability & Human Factor with Sharon Ayd appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Episode 36 – How to choose your PRRC with Erik Vollebregt
August 12, 2019 00:00PRRC means Person Responsible for Regulatory Compliance. With the new Medical Device Regulation it is mandatory to have one at your company. Let's review everything about this role and help you to choose the right person. The post Episode 36 – How to choose your PRRC with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Episode 35 – Digitalization of QA RA with Michael Kania
August 05, 2019 00:00Digitalization 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. The post Episode 35 – Digitalization of QA RA with Michael Kania appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Episode 34 – Real-World Data for Medical Devices with Alethea Wieland
July 29, 2019 00:00Real World Data is more and more important with all the new devices that can collect them. Then what can we do with them and how to present them to a regulator. The post Episode 34 – Real-World Data for Medical Devices with Alethea Wieland appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Episode 33 – Notified Bodies Lay Down Service with Erik Vollebregt
July 22, 2019 00:00One important piece of the puzzle for the new Medical Device Regulation is about Notified Bodies. More and more we receive the information that some of them decide to Lay Down Service. What are the consequences for manufacturers? What is a solution for them? Erik Vollebregt will be my guest on this episode. The post Episode 33 – Notified Bodies Lay Down Service with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Episode 32 – Pakistan Registration Process with Muhammad Sohail
July 14, 2019 22:59Pakistan Registration requirements for Medical Devices have been improved and leave more opportunities for Manufacturers. Muhammad Sohail, will share with us the situation of this market and the steps to register your products. The post Episode 32 – Pakistan Registration Process with Muhammad Sohail appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Episode 31 – First Regulatory Affairs Job with Karandeep Badwal
July 06, 2019 23:05Finding your first Regulatory Affairs Job can be a challenge. And Karandeep Badwal knows about that as he followed this journey. He is now Regulatory Affairs Contractor. Karandeep wanted to share with the audience some tips to be able to find quickly your first job. So don't miss those actionable tips. The post Episode 31 – First Regulatory Affairs Job with Karandeep Badwal appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Episode 30 – Promotional Compliance with Darshan Kulkarni
June 30, 2019 22:59The 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
Episode 29 – 5 Steps to create a QMS with Jason Lim
June 23, 2019 22:59Jason 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
Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2
June 16, 2019 23:01How 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
Episode 27 – OEM & OBL Model with Stefan Bolleininger [Part 1]
June 10, 2019 01:30The 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
Episode 26 – IVDR preparation with Andreas Stange
June 03, 2019 03:30Andreas 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
Episode 25 – EUDAMED secrets with Richard Houlihan
May 27, 2019 03:00EUDAMED 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
Episode 24 – Myths about consultants with Thomas McMann
May 20, 2019 04:00Are 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
Episode 23- TOP 10 criteria to select a CRO with Alethea Wieland
May 13, 2019 05:00Alethea 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
Episode 22 – Clinical Trial with Alethea Wieland
May 06, 2019 05:00What 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
Episode 21 – How to master Regulatory Affairs with Samantha Alsbury
April 29, 2019 05:00For 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
Episode 20 – What is a Blockchain with Khuram Malik
April 22, 2019 05:30Blockchain 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
Episode 19 – Rule 11 for Software Devices with Cyrille Michaud
April 15, 2019 03:30Cyrille 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
Episode 18 – QA RA Recruitment situation with Petra Ognjenovic
April 08, 2019 02:00Is 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
Episode 17 – Unannounced audit stories with Florent Guyon
April 01, 2019 04:00On 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
Episode 16 – From Disease to a Medical Device with Sean Hamilton
March 25, 2019 02:00Sean 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
Episode 15 – MDR & IVDR discussion with Erik Vollebregt Part 2
March 18, 2019 03:00On 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
Episode 14 – MDR & IVDR stories with Erik Vollebregt (Part 1)
March 11, 2019 02:00Erik 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
Episode 13 – Brexit Talk with Richard Young
March 04, 2019 05:00Richard 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
Episode 12 – How to create an ISO Standard with Marcelo Antunes
February 25, 2019 05:00Marcelo 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
Episode 11 – Medical Device Software Validation
February 17, 2019 09:40Bill 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
Episode 10 – Understand MDSAP with Angelina Hakim
February 11, 2019 06:00On 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
Episode 9 – Entrepreneurial journey with Ivan Perez Chamorro
February 03, 2019 10:00Show 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
Episode 8 – From Correction to Prevention with ODIAC
January 27, 2019 11:03Learn 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
Episode 7 – Make your KPIs Green again
January 20, 2019 11:55KPIs 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
Episode 6 – What are the 6 types of Medical Device Audits
January 12, 2019 15:02On 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
Episode 5 – Medtech Prediction 2019
January 06, 2019 11:422019 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
Episode 4 – UDI for Unique Device Identification
December 29, 2018 21:21UDI 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
Episode 3 – Is my Product a Medical Device in Europe?
December 20, 2018 14:04Medical 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
Episode 2 – New EU Medical Device Regulation MDR 2017/745
December 16, 2018 17:43The 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 ...
Episode 1 – Introduction to the Medical Device made Easy Podcast
December 14, 2018 23:04Within 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