PMCF is a key element of the Post-Marketing Surveillance process. As there were a lot of questions about it then I decided to ask Helene Quie some questions while I was at Medica 2019. The post Post-Marketing Clinical Follow-up with Helene Quie (PMCF) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
This is the last episode of 2019 and I wanted to summaries the situation and introduce you to my 2020 projects. The post I wish you a Happy New Year 2020 with Monir El Azzouzi appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
With the MDR, more and more clinical data are needed. But how will you collect them. David Rutledge will show you 6 ways to collect those data and the pros and cons for each of them. The post 6 ways to collect Clinical Data with David Rutledge appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Before to look at this episode, you should go to Part 1. On this second part we'll continue to discuss Class I up-classified situation and then pure Class I devices under MDR. The post Class I Medical Devices under MDR with Erik Vollebregt (PART 2) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
The MDR Corrigendum 2 is changing the rules for some class I devices under MDD that are up classified under MDR. Let's see what manufacturers should do. The post Corrigendum 2 – Changes for Class I Devices with Erik Vollebregt (Part 1) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
If you have a product and you want to evaluate if this is a Medical Device, then you need to follow the 3 steps that we will discuss on this episode. Heikki Pitkänen's platform is providing a solution for your to evaluate your device and he offers it for free to the listeners of this podcast. Thanks to him. The post How to evaluate your Medical Devices in 3 Steps with Heikki Pitkänen? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
What is the role of a Distributor within the new MDR 2017/745 and IVDR 2017/746. This is the question that I asked my guest who is working as distributor of Medical Devices in Norway. The post Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
When you are trying to create your product there is one question that you should answer: Should you focus on your product development or your documentation creation? Listen to our argument on this episode of the podcast. The post Medical Device School: Product Development or Documentation creation? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
EUDAMED is delayed but what should do Medical Device manufacturers to continue be compliant. Richard Houlihan is a EUDAMED expert and will help us understand. The post EUDAMED is delayed, so What? with Richard Houlihan appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
When creating your Clinical Evaluation Report or CER, you maybe need to perform a literature search. There is a certain method for that and we wanted to help you to understand it with Ed Drower from CiteMedical Solution The post Literature Search for your CER with Ed Drower appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
In this Bonus episode of Medical Device School we will talk about Gap Assessment tools. You know that when there is a regulation or something that you should put in place, you need to perform a gap assessment. To check where you are and if you are compliant to where you want to be. Let'S see if you follow our discussion with Stefan Bolleininger. The post Medical Device School: How to build a Gap Assessment Tool? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
After episode 47 on how to implement an eQMS, Jacob Sjorslev is now telling us how to validate an eQMS. This is something mandatory now since ISO 13485:2016. So listen carefully and download the giveaway, The post How to validate an eQMS with Jacob Sjorslev appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
An eQMS can be a necessary tool for your Quality Management System. This is why it's implementation should be executed as a project. Jacob Sjorslev will be your instructor and tell what to do and what to avoid. And Jacob will also make you an offer at the end of the episode. The post How to implement an eQMS with Jacob Sjorslev appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
On 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...
Some 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...
Justin 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 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...
There 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
In-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...
On 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...
This 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...
Networking 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...
How 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...
Let'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...
PRRC 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...
Digitalization 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
Real 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...
One 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...
Pakistan 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...
Finding 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...
