IEC 60601 is one of the most important standard to look at if you have an electrical medical devices. In this episode Leonard Eisner also called the IEC 60601 guy will help us understand the full situation. So be ready to learn a lot today. The post Best overview of IEC 60601 for Medical Device electrical equipment appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
In this monthly update we will review some hot topics that happened within the last weeks., the Notified Body Situation, the Guidance and standards update and finally what happened at Easy Medical Device. The post Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
UDI is new for Europe but already exist in the USA. We will explain to you what is important to understand for the EU version as there are some differences. Sylvia Reingardt from GS1 will be my guest and will share with us her knowledge and how GS1 can help. The post Learn UDI code for Medical Devices with Sylvia Reingardt appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
What is IEC 62304? This is the question I asked Adnan Ashfaq from Pharmi Med Ltd. The answer is helping a lot to understand the interaction with other standards and regulations. Enjoy it! The post Understand IEC 62304 for Medical Device Software with Adnan Ashfaq appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Team-PRRC is invited to this episode to help us understand how to become a PRRC. This is a new role required for Medical Device manufacturers. In this episode, we will also share with you what TEAM-PRRC can do to help you. The post How to become a PRRC with TEAM-PRRC (EU MDR & IVDR) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
During this update, we will talk about the Coronavirus situation, the Notified Body accredited, the CEN CENELEC mandate for Harmonized Standards, the Green Belt Certification Program. A lot to say and also a Trailer for the EU Commission Telenovela. The post Medical Device News – June 2020 Update appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Shokoufeh from Straumann in Switzerland is sharing with us her journey on the EU MDR world. She will tell us what helped the team to reach this success and what she would have changed. The post The secrets to being EU MDR certified with Shokoufeh Khodabandeh appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Process Validation is an important but difficult topic. You should not only be good at engineering but also at explaining to your staff. Because a good validation worth nothing if the Staff is not following the instruction. Listen to Monir El Azzouzi and Adnan Ashfaq sharing with you their experience. The post How to perform your Process Validation with Adnan Ashfaq (IQ OQ PQ) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
In this episode, I will help you understand the power of Internal Audits. Some of you are using that just because ISO is requiring it but you can get so much out of it. The post How to execute your Internal Audits? (Medical Device companies) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
The Month of May 2020 was supposed to be the beginning of the EU MDR. This was not as the new date is on May 26th, 2021. We will celebrate the Non-Anniversary of it and also talk about IVDR, MDCG, Notified Bodies, Coronavirus, Easy Medical Device podcast, LinkedIn Live... So be ready and push play. The post Medical Device News – May 2020 Review with Monir El Azzouzi appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Sufficient Clinical Data is a new vocabulary introduced with the EU MDR 2017/745 but this is still unclear what is sufficient and what is too weak. Bassil Akra from QUNIQUE Group will explain to you what you should do in the episode where a former Notified Body employee is giving you advises related to his experience. Bassil is also offering a webinar to people that want to learn more about sufficient clinical data. The post What means Sufficient Clinical Data with Bassil Akra (EU MDR) appeared ...
If you are looking for a Notified Body for your Medical Device, you maybe have some difficulties to find one. In this episode, Bassil Akra from TÜV SÜD will explain to you the reason of this. The post What is the Notified Body situation? (Bassil Akra from TUV SUD) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
I'll answer one of the most frequently asked question I receive from my followers. How to get ISO 13485 certified? Don't miss the links on the show notes to get more material to read. The post How to get ISO 13485 certified? (Quality Management System) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
You are maybe a Digital Health Application developer, so this podcast will be of a great interest for you. If you don't place to make your device available in germany, than DIGA may help you change your mind. Listen to Stefan Bolleininger who will explain to you how your customers can get reimbursed. The post How to get your Digital Health Application reimbursed in Germany? (DIGA) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Medical Device News April 2020- We will talk about how Coronavirus is shaking the Medical Device World, the Notified Body Situation, the MDCG guidances and the Easy Medical Device events. Enjoy! The post Medical Device News – April 2020 Regulatory Update appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Don't worry, we will not show you any equation for calculating the sample size. But we will show you how to do it and why you should be careful on some important parameters. Then you can see some examples in the ebook provided by Jon. The post How to calculate your sample size with Jon Bergsteinsson appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
This week there was an important vote regarding the proposal to delay the EU MDR until May 26, 2021. The parliament adopted it and we wait for the publication on the official journal. But what will be the consequence for Medical Device Manufacturers, Notified Bodies... The post The 1-year delay for the EU MDR 2017/745 with Erik Vollebregt appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
If you are not working in QA RA you maybe don't understand this. But sometime people don't want to follow the process not because they want to annoy you but because they are afraid of some consequences. And they try then to find other ways. Let's explore them with Karandeep Badwal The post Medical Device School – Why are Staff hiding problems to QA & RA? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Did you know that the EU MDR is amending 2001/83/EC for Medicinal Products. This may have some consequences for your products if it involves a Drug-Device combination. Monir El Azzouzi and Theresa Jeary are explaining to you what should be done. The post MDR & Drug-Device Combination Products with Theresa Jeary appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
The month of March 2020 is over but there was a lot of information provided regarding the Medical Device industry so let's listen to the different news with Monir El Azzouzi The post Medical Device News – March 2020 Review (EU MDR) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
This is an important question if you understand the rule for a transition period of your device under EU MDR article 120(3). If you perform a significant change then you may be prepared for the consequences. Let's see what are the advice of Erik Vollebregt if you reach this situation. The post What is a Significant Change for your Medical Device? with Erik Vollebregt appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
In this episode we will focus specifically on Medical Device class I that are "Sterile", with measuring function" or "Reusable surgical instruments". Elem Ayne will help us to understand what you should prepare to be compliant. The post All about Class Is, Im and Ir with Elem Ayne (EU MDR 2017/745) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Do you recall those movies with hackers that are taking the control of an hospital or of your pacemaker. Is this Science Fiction or reality. On this episode, Monir and Erik will explain to you how to secure your medical devices if they are connected to a network. The post Cybersecurity for your Medical Devices with Erik Vollebregt appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
In this episode, we will talk about, Coronavirus, MDCG, Notified Body, US guidance, Podcast episodes, LinkedIn Live... So don't miss it. The post Medical Device Regulatory Update – February 2020 appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
It is clear that a Manufacture of a Medical Device need to have a Quality Management System. But what is the answer for an importer, Distributor or Authorized Representative? You'll hear it on this episode where Erik Vollebregt will help us understand the requirements of the regulation. The post Do your Economic Operators need a Quality Management System? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
The intended purpose of your device is critical but a lot of manufacturers are nor really putting much effort to write a good one. Check on this episode with Cesare Magri why this is important and how to create it correctly. The post Create your intended purpose with Cesare Magri (Medical Device) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Your Economic Operators do have some responsibility per EU MDR and IVDR. What should they check? Monir El Azzouzi and Erik Vollebregt will help you understand that on this bonus episode. The post Medical Device School: What should verify your Economic Operators? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Many medical device manufacturers try to solve a puzzle regarding their Low risk medical devices. How to write Clinical Evaluation for it without data? here is the solution. Download the presentation. The post Clinical Data for Low Risk Medical Devices with Robert van Boxtel appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
In this episode we will explain you the way that Economic Operators are controlled. This may seem obvious but the answer can be different per Economic Operator. So listen to this short episode of Medical Device School to understand everything. The post Medical Device School – Who controls your Economic Operators? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Brexit, Swixit, Turkxit. These are the topics of this episode of the Podcast. We will try to help you understand all these -XIT and what is the impact to Medical Device manufacturers. The post Are Brexit, Swixit, and Turkxit a reality? with Erik Vollebregt appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
