Shows / Medical Device made Easy Podcast
Episodes
- Medical Device made Easy Podcast
What are the surprises during MDR & IVDR transition? [Erik Vollebregt]
There was an announcement earlier about the transfer of the Expert Panel for EU MDR & IVDR to the European Medicine Agency. So Pharma will take care of this…
- Medical Device made Easy Podcast
How to sell Medical Devices online in the EU and US?
Since the implementation of EU MDR, there was a new phenomenon about Medical Device online sales. Online sales see their submissions to platforms like amazon…
- Medical Device made Easy Podcast
What lesson did we learn doing Clinical Evaluations? [Cesare Magri]
Since MDR is live we get from surprises to surprises. And we wanted in this episode to share with you some lessons learned regarding Clinical Evaluation. You…
- Medical Device made Easy Podcast
Why do we need the Common Specification for Class D IVDR?
For IVDR products, there is more and more information that is coming. So we make a small summary with Andreas Stange from TÜV SÜD and then we will discuss…
- Medical Device made Easy Podcast
Medical Device News – March 2022 Regulatory Update
HOT TOPICS IVDR Common Specification certain Class D IVD – https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13304-In-vitro-diagno…
- Medical Device made Easy Podcast
Why would you need a Swiss Authorised Representative and Importer?
Since May 26th, 2021 Switzerland is now considered a non-EU country for Medical Devices. So to sell your products in Switzerland you need a Swiss Authorized…
- Medical Device made Easy Podcast
How to be great at Management Reviews? [ISO 13485]
When we talk about Management Review, this is not really obvious how this should be done. In this video, I will try to explain to you what is expected to be…
- Medical Device made Easy Podcast
Why Design History File (DHF) is so important? [Alexandros Savvidis]
DHF or Design History File or DMR or DHR or … What does all this mean? We will focus on DHF but we’ll also provide an explanation of the other…
- Medical Device made Easy Podcast
Medical Device News: February 2022 Regulatory Update
The February 2022 Regulatory Update contains a lot of information that may help you to maintain your team up-to-date with the new requirements. Agenda: IVDR…
- Medical Device made Easy Podcast
MDCG 2021-27 Placing on the market & Re-labelling with Erik Vollebregt
The MDCG 2021-27 on Articles 13 and 14 of the EU MDR 2017/745 is creating some problems because of the vocabulary used. Erik Vollebregt, a lawyer at Axon…
- Medical Device made Easy Podcast
How to interview your QA RA Candidates? [Mitch Robbins]
If you are a Quality or Regulatory affairs hiring manager then you may need to understand how to interview your candidates. I have asked Mitch Robbins from the…
- Medical Device made Easy Podcast
How to accelerate your Laboratory Test Results? [Christoph Lindner]
I am sure you were in this situation where you had to execute some Laboratory Tests for the compliance of your medical device and thought that you just need to…
- Medical Device made Easy Podcast
Medical Device News – January 2022 [Happy New Year]
Happy New Year 2022. All my best wishes for this year. For all the updates. check the links below. Links: Green Belt Edition 15 – January 2022…
- Medical Device made Easy Podcast
What happened in 2021? Summary for the Medical Device Industry
The year 2021 was really full of updates for the Medical Device Industry. I can understand that it goes so fast you cannot follow. So I tried to summarize the…
- Medical Device made Easy Podcast
The Step-by-Step recipe to get MDR & IVDR Certified
For this episode, I wanted to show you how it is possible to plan your MDR & IVDR certification. This is a question that people ask me when they reach out…
- Medical Device made Easy Podcast
Which devices cannot be Custom-made? [Erik Vollebregt]
The EU MDR is changing a lot of things for medical devices, and even on Custom-made. The definition changes and has a huge impact on already marketed products…
- Medical Device made Easy Podcast
Medical Device News: December 2021 Regulatory Update
EUDAMED Commission implementing regulation 2021/2078: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2078 EUDAMED webpage…
- Medical Device made Easy Podcast
Let’s unleash “MDR Classification surprises” [MDR 2017/745]
Recently the MDCG guidance for Medical Device classification was published. And I wanted to have someone to help us decode it. Frank Matzek accepted to share…
- Medical Device made Easy Podcast
How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD]
One of the most stressful situations in the medical device business is the selection and the work with Notified Bodies. Why? Because there are less than what…
- Medical Device made Easy Podcast
Is it possible to Private Label a Medical Device under MDR & IVDR?
If you are a company buying products from a supplier and then putting your brand on it to sell it in Europe, then you are an Own Brand Labeller or Private…
- Medical Device made Easy Podcast
How to improve your QA RA Communication with Lesley Worthington?
We always think that what is most important in QA RA is to know the regulation. NO!. What is most important is to be able to transmit this knowledge to the…
- Medical Device made Easy Podcast
Medical Device News – November 2021 latest update
In this episode of the Podcast we will review: IVDR proposal to delay transition periods Cobalt on medical devices as CMR Artificial Intelligence MDCG guidance…
- Medical Device made Easy Podcast
How does the EU Commission plan to save IVDR 2017/746?
A few weeks ago, we were surprised to hear that the EU Commission issued a proposal to delay some products from applying IVDR 2017/746 by my 26th, 2022. So we…
- Medical Device made Easy Podcast
How to comply with MDR when products contain CMR Substances?
In this episode, we will discuss CMR which are some substances that can be dangerous for your health. They are classified by legislation and we will explain to…
- Medical Device made Easy Podcast
EUDAMED Update: Should you register your medical devices now?
Recently EUDAMED made a major Update which was the release of the Device registration module. This is something that all Medical Device manufacturers need to…
- Medical Device made Easy Podcast
Medical Device News – October 2021 Regulatory Update
Here are all the topics that we will cover during this regulatory update. Don’t forget to contact easy medical device if you need an EU-authorised…
- Medical Device made Easy Podcast
Why does an Importer/Distributor need to appoint a Notified Body?
Recently MDCG issued the guidance on Article 16 of the EU MDR & IVDR. This provided some surprises. So now in certain circumstances, some importers or…
- Medical Device made Easy Podcast
How to collect Clinical Data within the 21st Century [Jon Bergsteinsson]
Clinical Data is key for the Medical Device Regulation MDR 2017/745. Today on this Podcast Episode, I have invited Jon Bergsteinsson from Smart Trial. And we…
- Medical Device made Easy Podcast
How to manage the IVDR transition period? [IVDR 2017/745]
We are at 9 months of the EU IVDR 2017/746 date of application. So let’s t talk of the Transition period for such products. We have done that also for…
- Medical Device made Easy Podcast
Is it a good idea to sue my Notified Body? [Erik Vollebregt]
First of all, I am not encouraging anyone to sue anyone. This is only educative content to know what is possible and what is the best strategy to do it. We…
- Medical Device made Easy Podcast
Medical Device News – September 2021 Latest Updates
This month we will cover a lot of specific rules that are applied in some countries: USA UK France Finland Switzerland And then we’ll look at Events…
- Medical Device made Easy Podcast
How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD)
Software as a Medical Device is really a difficult topic. First, because it is quite new in the EU Regulation, and second because we cannot make a generality…
- Medical Device made Easy Podcast
Better to be a Consultant or a Full-time employee? [Lifescience industry]
Let’s describe to you the life of a Healthcare industry consultant with Smahan Toughrai. Within this episode, we will ask the question like: Why would we…
- Medical Device made Easy Podcast
What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD]
After few months of MDR, I proposed TÜV SÜD share with us the most common mistakes they find during their audits. And Martin Witte accepted to summarize some…
- Medical Device made Easy Podcast
Medical Device News – August 2021 Regulatory Update [MDR & IVDR]
On the agenda for this month Episode we will talk about the latest news and here are few topics that I will present to you: Team-NB Position Paper Harmonized…
- Medical Device made Easy Podcast
How to implement Vigilance Reporting for MDR and IVDR?
Within this Masterclass, I will explain to you how to implement a vigilance reporting system with all the links for all the documents we talk about. Vigilance…
- Medical Device made Easy Podcast
System and Procedure Pack the RETURN with Erik Vollebregt
In this second episode on System and Procedure Pack, we answer more questions about this way to place devices on the market. Erik got some experience with the…
- Medical Device made Easy Podcast
How to interpret the first Expert Panel Opinion? [Bassil Akra]
We received the First Expert Panel Opinion and by reading it you can say a lot. So to help us have a good interpretation of it, I have asked Bassil Akra to be…
- Medical Device made Easy Podcast
Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA]
In this episode of the podcast, we will provide an update on the Medical Device industry for the period June July 2021. Who is Monir El Azzouzi? Monir El…
- Medical Device made Easy Podcast
How to build your State-of-the-art for your Medical Devices?
State-of-the Art is an important topic but not well understood. It’s why I have invited Hakan Inan from Requalite to help us get a better understanding…
- Medical Device made Easy Podcast
How Intellectual Property is linked to the Medical Device Regulation?
In this episode of the podcast, I wanted an expert to answer the question about IP related to Medical Devices. A lot of people are willing to understand how…
- Medical Device made Easy Podcast
How to perform a good Clinical Investigation with Helene Quie
Clinical Investigation is one of the toughest process within the EU MDR 2017/745. If you have to perform one for your Medical Devices then it can be a long and…
- Medical Device made Easy Podcast
How to perform a Biological Evaluation for your Medical Device?
We talked a lot about the regulatory requirements for your Medical Devices. Now let’s talk about something more technical which is the Biological…
- Medical Device made Easy Podcast
Medical Device News – June 2021 Update [EU MDR Date of Application]
Ok, this month the EU MDR is LIVE so we will talk about that. The date of application for EU MDR 2017/745 was May 26th, 2021 and there is a lot of information…
- Medical Device made Easy Podcast
EU MDR Survey: What is the Industry’s opinion? [Catherine Higginson]
Last year we had reviewed the result of the EU MDR Survey made by Climedo and this year we check the difference. Do you think that there will be a big change?…
- Medical Device made Easy Podcast
MDR is coming so brace yourself with Erik Vollebregt
MDR is coming In 1 week and before that, I asked Erik Vollebregt from Axon Lawyers about some questions that I receive. We will talk about: – EU MDR IVDR…
- Medical Device made Easy Podcast
FDA: Is the Emergency Use Authorization worth it? (EUA)
In this episode of the Podcast, we will explain to you what is the Emergency Use Authorization (EUA) that can be started in the US. And to help us, I have…
- Medical Device made Easy Podcast
Medical Device News – May 2021 Update [EU MDR 2017/745]
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big…
- Medical Device made Easy Podcast
Checklist – What is important before the EU MDR Date of Application?
Wahoo!! We are close to it now. The EU MDR 2017/745 Date of Application is arriving quickly. So for this episode, I wanted to check with you if you are ready…
- Medical Device made Easy Podcast
How to perform correctly a Merger & Acquisition during the MDR transition?
Subscribe Merger and Acquisition sound like a financial topic but you’ll see that all the ways lead to Quality and Regulatory Affairs. In this episode…
- Medical Device made Easy Podcast
How to write your Performance Evaluation? [IVDR 2017/746]
Subscribe In this episode I have invited Hakan Inan from Requalite to help us understand the situation for In-Vitro Diagnostic device manufacturers and also on…
- Medical Device made Easy Podcast
Medical Device News – April 2021 Update [EU MDR & IVDR]
Subscribe Let’s update you on the Medical Device situation. In this episode we will talk about: Countdown until date of application of EU MDR Swixit with…
- Medical Device made Easy Podcast
Will it be really difficult for IVD manufacturers? [IVDR 2017/746]
Subscribe We talked a lot about the EU MDR and the difficulty for some manufacturers to transition to this new legislation. But today we will explain why IVDR…
- Medical Device made Easy Podcast
How to create a Label under MDR? (Questions & Answers)
Subscribe This podcast episode is following a presentation I have made during the Greenlight Guru Summit on EU MDR and IVDR. I have explained how to create a…
- Medical Device made Easy Podcast
How System and Procedure Pack are regulated under EU MDR?
Subscribe Let’s discuss System and Procedure Pack. We usually talk about medical devices like as an object that is used in the healthcare industry. But…
- Medical Device made Easy Podcast
How to import your Medical Devices with an Independent Importer?
Subscribe With the EU MDR 2017/745 and IVDR 2017/746 the role of Economic Operators is becoming clearer. In the case you are located outside of Europe and you…
- Medical Device made Easy Podcast
What is the Medical Device News? [March 2021 update]
Subscribe This month we will review what happened within the Medical Device Industry and there was some updates. Here is the agenda: EUDAMED Covid19 Language…
- Medical Device made Easy Podcast
The best design methods for successful development? [Jon Speer]
Subscribe I am really honored to have within this episode of the Podcast Jon Speer. I was already following him before I started Easy Medical Device and now I…
- Medical Device made Easy Podcast
How to find a QA RA job for Medical Devices? [Karandeep Badwal]
Subscribe If you find it difficult to get a job in QA RA for Medical Devices, then listen to this episode where Monir El Azzouzi and Karandeep Badwal are…
- Medical Device made Easy Podcast
What is the QA RA Mindset with Michelle Lott
Subscribe Michelle Lott and I are discussing our Experience in the Quality and Regulatory affairs area. We will help you define what is compliance and how we…