Medical Device made Easy Podcast Archiv
417 Episoden
1 Minute
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
The post New rules for the In-Vitro Diagnostic Industry with Maurizio Suppo appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Learn Post Market Surveillance with Natasha Bankowski appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Product Equivalence for Clinical Evaluation Report (CER) with Helene Quie appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Episode 39 – Networking at Medical Device events with Lynda Wight appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Episode 38 – Be the Best Candidate Ever with Mitch Robbins appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Episode 37 – Usability & Human Factor with Sharon Ayd appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Episode 36 – How to choose your PRRC with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Episode 35 – Digitalization of QA RA with Michael Kania appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Episode 34 – Real-World Data for Medical Devices with Alethea Wieland appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Episode 33 – Notified Bodies Lay Down Service with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Episode 32 – Pakistan Registration Process with Muhammad Sohail appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Episode 31 – First Regulatory Affairs Job with Karandeep Badwal appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Episode 30 – Promotional Compliance with Darshan Kulkarni appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Episode 29 – 5 Steps to create a QMS with Jason Lim appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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 post Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2 appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
