Shows / Medical Device made Easy Podcast
Episodes
- Medical Device made Easy Podcast
What if your Medical Device Company goes Bankrupt?
This is really a difficult situation if your company goes bankrupt. But now the idea is what to do regarding the products that are still on the market. You…
- Medical Device made Easy Podcast
Technical Files Inconsistencies Identified by Notified Bodies
This week with Adam Rae we will talk about the Technical Files inconsistency that we noticed while working on some projects. Adam will provide his list of…
- Medical Device made Easy Podcast
The truth about the UK vs EU situation
Since Brexit, the UK market is really trying to find a way to come back to normal and extract themselve from the EU legislation. They are doing it step by step…
- Medical Device made Easy Podcast
Medical Device news – May 2023 Regulatory Update
•Team-NB Sector Survey 2022 :https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-MD-Sector-Survey-PressRelease-20230411.pdf • MDCG planning…
- Medical Device made Easy Podcast
Transition to Agile for Software as Medical Device
We start to talk more and more of Software as Medical Device or SaMD. This time we will check with you how to develop a Software and transition to the Agile…
- Medical Device made Easy Podcast
Prepare your audit like a PRO
If you are selling a Medical Device that is not a class I, then you know that you have to go through an audit with a Notified Body. So let’s discuss how you…
- Medical Device made Easy Podcast
What is a SOUP for your Software Development?
In this context SOUP is not a dish but Software Of Unknown Provenance which is the term used for Software that was not created by you. Christian Kaestner from…
- Medical Device made Easy Podcast
Medical Device News – March 2023 Regulatory Update
► Medboard platform: https://www.medboard.com/ ► Podcast page: https: //podcast.easymedicaldevice.com/226-2/ ► MEDBOARD SHOW NOTES LINKS:…
- Medical Device made Easy Podcast
How to perform Risk Management for a Software ?
In this episode, Bijan Elahi will help us perform risk management for SaMD and give us some tips on the best strategies. Bijan is also the author of the book…
- Medical Device made Easy Podcast
How to create a Proactive Postmarketing Surveillance? [EU MDR]
The EU MDR is requiring more transparency and the PMS has a lot to play in it. In this episode, we will explain to you a difference that is visible for PMS…
- Medical Device made Easy Podcast
What you should know about Vigilance Reporting for Medical Devices?
Vigilance Reporting is a process you should have but don’t want to use. In fact not having any vigilance reporting is a sign that your product is doing well…
- Medical Device made Easy Podcast
Medical Device News: March 2023 Regulatory Update
Here is your Regulatory Update for the month of March 2023. Check all the links on Medboard Platform…
- Medical Device made Easy Podcast
Prepare your transition from Class I to Class Ir
The EU MDR is planning to be really challenging for Class I reusable Surgical Instruments as they will need to move to Class Ir. In this Episode, Tautvydas…
- Medical Device made Easy Podcast
SaMD international reach – What to consider?
We are in a global world, so normally what is good for the EU can be also good for other countries. But here the only barrier is local law. This is mainly what…
- Medical Device made Easy Podcast
Biological Evaluation: Top Big mistakes
In this podcast episode, Laura and Paul will share with us the big mistakes done by some Medical Device manufacturers when they are considering Biological…
- Medical Device made Easy Podcast
Medical Device News: February 2023 Regulatory Update
Here is your Regulatory Update for the month of February 2023. Check all the links below – EU amendment of the EU MDR and IVDR…
- Medical Device made Easy Podcast
How to do Post-Marketing Surveillance in the US (vs EU)?
We talk a lot about Post Marketing Surveillance in Europe with EU MDR, MDCG, and all the rules to follow. But when you hear about how this is done in the US…
- Medical Device made Easy Podcast
How to evaluate Benefit-Risk Ratio for Medical Devices?
The evaluation of the Risk-Benefit ratio is key for Risk Management Files per ISO 14971 or when you build your Clinical Evaluation Report or when you need to…
- Medical Device made Easy Podcast
Breaking News: EU MDR Extension Proposal is out for consultation
Finally, a proposal is now available, and we wanted to discuss it and identify if there are any surprises. Erik Vollebregt from Axon Lawyer is helping us…
- Medical Device made Easy Podcast
How to improve the relationship between QA – RA and Marketing?
In the Medical Device world, you need to work as a team. Sometimes it is really difficult and we will discuss that with Omar M. Khateeb. The relationship…
- Medical Device made Easy Podcast
Medical Device News: January 2023 Regulatory Update
EU MDR extension Implementation of the Medical Device Regulation https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf Provisional Agenda 9th…
- Medical Device made Easy Podcast
Grow your LinkedIn Profile with Karandeep Badwal
Getting some visibility is the key to growing your LinkedIn Profile. And on this episode, we tell you how to be more visible or help build a community. As…
- Medical Device made Easy Podcast
Is EU MDR extended? with Erik Vollebregt
On December 9th, 2022, the EU Commission made a proposal to extend the transition period of the EU MDR 2017/745. But some people think this is already done…
- Medical Device made Easy Podcast
MDCG, Team-NB, BVMed & Team-PRRC tell you all about PRRC
Imagine that you have a question to ask the EU Commission, your Notified Body, or any association about being a PRRC. Then this is the episode to listen to…
- Medical Device made Easy Podcast
Medical Device News – December 2022 Regulatory Update
HOT TOPICS Europe Common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745…
- Medical Device made Easy Podcast
How to choose the best Sterilization Method for Medical Devices?
Sterilization for medical devices is a critical topic. Now when you are developing your Medical Device, you should start by asking which sterilization process…
- Medical Device made Easy Podcast
Why Risk Management is important to Medical Device development?
Risk Management is a discipline of its own within the Medical Device field. In ISO 13485, EU MDR 2017/745, IVDR 2017/746, FDA QSR, MDSAP… All of them…
- Medical Device made Easy Podcast
Regulatory Pathway: How to reach the US market? [510k exempt]
You maybe ask yourself how to get to distribute your Medical Device in the US? Then listen to the story of MysteryVibe with their devices. He will answer…
- Medical Device made Easy Podcast
Your Software/IVD clinical report is completely WRONG!
In this episode, Cesare Magri from 4BetterDevices will explain to us why medical device manufacturers are making mistakes when they try to gather Clinical…
- Medical Device made Easy Podcast
Medical Device News – November 2022 Regulatory Update
This month we will have some updates on: Annex XVI ACRAS Event MDCG Agenda Commission Contact update Team-NB position paper on Off-label use Team-NB position…
- Medical Device made Easy Podcast
Can you go to Jail as a PRRC? [Elem Ayne]
We are starting to get more and more questions on the PRRC and I think this episode will help you a lot to understand what your responsibility is when you sign…
- Medical Device made Easy Podcast
How to be MDSAP certified for your Medical Devices?
Within this episode, I will explain to you how you can be MDSAP certified for your Medical Devices. The agenda for this episode is the following: What is…
- Medical Device made Easy Podcast
Medical Device News – October 2022 Regulatory Update
Here is your Regulatory update. Don’t forget to check the show notes for all the links we will mention on this video. Who is Monir El Azzouzi? Monir El…
- Medical Device made Easy Podcast
What do Clients, Followers, Team, … think of Easy Medical Device?
This week, we reached 200 episodes of the Podcast and I asked some of the stakeholders to share feedback on how this helped them achieve their objectives. I…
- Medical Device made Easy Podcast
How to select your Notified Body and understand the full process?
The selection of Notified Bodies in Europe can be a real challenge and I will explain to you in this Podcast episode how to do it so you can understand the…
- Medical Device made Easy Podcast
How to become the best PRRC ever? [Ronald Boumans]
Becoming the best PRRC ever is something that all PRRC should go for. The PRRC role is really important to avoid some situations that happened like the PIP…
- Medical Device made Easy Podcast
Why do you need an Initial Importer for the US Market?
You get a call from the US Customer border which are telling you that your products are blocked. Why that? Maybe because you have no importer defined for these…
- Medical Device made Easy Podcast
Medical Device News: September 2022 Regulatory Update
Here are the links to the Regulatory Updates HOT TOPIC EUDAMED Timeline https://health.ec.europa.eu/system/files/2022-07/md_eudamed_timeline_en.pdf EU Call for…
- Medical Device made Easy Podcast
SaMD or SiMD – How to create your Design Dossier?
If you have developed a Software and you discover that it is considered a Medical Device, then what to do? Or your Software is inside a Medical Device so is…
- Medical Device made Easy Podcast
New Blue Guide – What is the impact on Medical Devices?
The new Blue Guide is out. So what are the changes for Medical Device Manufacturers? Erik Vollebregt will give us his analysis and also some revelation on the…
- Medical Device made Easy Podcast
Why are we not Discontinuing your Products?
This is really a good question. Sometimes, we are looking at the portfolio of some companies and ask “How many products on this portfolio are sold in…
- Medical Device made Easy Podcast
When you think “510k” but FDA says “DeNovo” with Spencer Jones
This episode will explain to you the journey of the company Lineus Medical when they tried to register their products in the USA. Initially, they prepared the…
- Medical Device made Easy Podcast
How to create your Technical Documentation? [EU MDR and IVDR]
The creation of a Technical File or Technical Documentation for CE marking is really a challenge sometimes. After successfully passing audits with my…
- Medical Device made Easy Podcast
Maybe you need a Cleanroom? Let’s check with Philippe Bourbon
Cleanroom is an equipement that a lot of Medical Device manufacturer need to have. But do you really need it? How much does it cost? How to qualify it? How to…
- Medical Device made Easy Podcast
AI Act vs EU MDR 2017/745 are they compatible? [Erik Vollebregt]
If you are working in the development of Software, then this is maybe something that will be interesting for you. The EU is preparing legislation for…
- Medical Device made Easy Podcast
Medtech Europe Forum interviews (MDR, EUDAMED, CER & MECOMED)
During my visit to the Medtech Europe Forum in Barcelona in May 2022, I had the chance to interview key people in the industry. I am sharing these interviews…
- Medical Device made Easy Podcast
Medical Device News – July 2022 Regulatory Update
This month the Regulatory update will contain a lot regarding Artificial intelligence for medical devices. All the links that are mentioned can be downloaded…
- Medical Device made Easy Podcast
Attention! 1 year before UKCA is the law for Medical Devices in the UK
This episode will alert you about the UKCA deadline for the UK market. So if you are selling products to the UK or if you plan to, you need to listen to what…
- Medical Device made Easy Podcast
Why is it great for Importers to be ISO 13485 certified? [Cristina Miroescu]
When we think of ISO 13485 certificate we mainly associate it with Medical Device manufacturers. But this can be also associated with other Medical Device…
- Medical Device made Easy Podcast
What are some Quality Common Mistakes? [Karandeep Badwal]
In this episode, Karandeep Badwal will introduce you to the common mistakes that we can see within your company for Quality and Regulatory affairs: Software…
- Medical Device made Easy Podcast
Medical Device News: June 2022 Regulatory Update
Here is the news of the month. Enjoy. NEWS Swiss: MRA situation for IVDR; https://ec.europa.eu/health/document/download/8dd260fd-0b67-415b-bf1e-36bdf8681674_en?…
- Medical Device made Easy Podcast
Let’s introduce you to our eQMS SmartEye with Anindya Mookerjea
Big news, with my partners we have developed an eQMS called SmartEye!!! and we wanted to share with you why an eQMS is needed. For that, I have invited Anindya…
- Medical Device made Easy Podcast
What to learn about the EU Medical Device situation? [Erik Vollebregt]
The Medtech Forum occurred this year in Barcelona between May 3-5, 2022 During this conference, we recorded a podcast episode with Erik Vollebregt to summarize…
- Medical Device made Easy Podcast
What happens after the IVDR Date of Application with Colm O’Rourke
The IVDR 2017/746 will become live on May 26th, 2022 and this will be the big day for a lot of IVD companies. To talk about the situation under IVDR, I have…
- Medical Device made Easy Podcast
How to certify your Software as a Medical Device? (SaMD)
Do you have a Software as a Medical Device or maybe you plan to have one? Then listen to this episode with Vivek Thakkar which will provide you some insight on…
- Medical Device made Easy Podcast
Medical Device News: May 2022 Regulatory Update
Below are all the topics we will discuss during this episode. Don’t miss the latest updates. EU EUDAMED EUDAMED & Certificate…
- Medical Device made Easy Podcast
Training Process – What are the mistakes to avoid? [ISO 13485]
The training process can create a lot of non-conformances during audits and this is why we will try to explain to you how to avoid that. Rod and Katie from…
- Medical Device made Easy Podcast
How your PMCF is evaluated by your Notified Body? [Matthias Fink]
PMCF is something that was existing before with MDD 93/42/EC but this is more in focus now with the new EU MDR 2017/745. In this episode, I have invited…
- Medical Device made Easy Podcast
How to prepare an Audit with a Front Room & a Back Room?
When you get audited, the configuration Front Room Back Room can help you a lot. But how to prepare for it? How to communicate between them? What are the rules…
- Medical Device made Easy Podcast
Medical Device News: April 2022 Update
HOT TOPIC Joint implementation and preparedness plan for Regulation 2017/746: https://lnkd.in/dasedpRA MDCG 2019-9 Rev 1 – SSCP update…