Medical Device made Easy Podcast
Episodes
Are you more Corrections or Corrective Actions or Preventive Actions?
21 May 2024
Contributed by Lukas
Do you have to manage complaints, CAPA, Non-conformances, audits, management reviews… for your company. Then you need to put in place actions. Today...
How to select and evaluate your Contract Manufacturer?
13 May 2024
Contributed by Lukas
Medical Device manufacturers can also involve third party companies to manufacture their devices. We call them Contract Manufacturers. But they are on...
Quality Field Service for Medical Devices?
07 May 2024
Contributed by Lukas
Michael Israel from Zuper.co is helping us understand the world of Field Service and then we can understand better how some information collected by F...
Medical Device NewsMAY 2024 Regulatory Update
02 May 2024
Contributed by Lukas
EUNotified BodiesTUV SUD Denmark under MDR –Welcome to the Brother or Sister: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=150a0...
Why and how to build a Quality Culture?
23 Apr 2024
Contributed by Lukas
A quality culture seem to be a nice to have. But after listening this podcast episode with Lesley Worthington, you will see that it is worth to build ...
What is the impact of AI Act on Medical Devices?
16 Apr 2024
Contributed by Lukas
The AI Act or Artificial Intelligence Act is now a reality. But what does it mean for the Medical Device industry and what should you do within your Q...
Radiation Sterilisation Master File (ISO 11137 & 11607)
09 Apr 2024
Contributed by Lukas
If your products need to be sterilized, then you will need to prove that the sterilization process is validated and continues to work all through the ...
Medical Device News April 2024 Regulatory Update
04 Apr 2024
Contributed by Lukas
Sponsor:Medboard: https://www.medboard.com/EUMDR and IVDR national languages update - France accepts EnglishMDR: https://health.ec.europa.eu/document/...
ow to benefit from Surveys to build Clinical Evidence?
26 Mar 2024
Contributed by Lukas
Since EU MDR and IVDR launched, there is a phenomenon that raised which is the use of surveys to gather clinical data. So we wanted to share with you ...
How to do Postmarketing Surveillance the right way?
19 Mar 2024
Contributed by Lukas
The EU MDR and IVDR is a bit more demanding on Postmarketing Surveillance. In this episode we will explain to you from the eye of an auditor what they...
FDA aligns QMSR with ISO 13485?
12 Mar 2024
Contributed by Lukas
The FDA announced the alignment of QMSR to the ISO 13485 standard. So now the question is: What does it change for me? Do you need to update your full...
Medical Device News March 2024 Regulatory Update
06 Mar 2024
Contributed by Lukas
Sponsor:Medboard EUEU proposal to prevent shortage - And other things: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-d...
New EU Proposal - EUDAMED, IVDR & Shortage
27 Feb 2024
Contributed by Lukas
In January 29th, 2024, the EU Commission issued a Proposal that discuss mainly the shortage of Medical Devices, the EUDAMED availability and the IVDR ...
Will EtO gaz become a Medical Device?
20 Feb 2024
Contributed by Lukas
When you are willing to sterilise your Medical Devices, you maybe think of EtO or Ethylene Oxyd as the method. So if you are on that case, there is a ...
How to get your interview prepared?
13 Feb 2024
Contributed by Lukas
You are maybe about to take a new job and you find out this episode of the podcast on how to prepare for an interview. I must say that we have invited...
Medical Device News february 2024 Regulatory Update
07 Feb 2024
Contributed by Lukas
EUTransition to the IVDR and EUDAMED Roll Out -An extension? Never !!!!!: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-proposal.PDFMe...
Why you should use Pre-Submission or Q-Sub with FDA?
30 Jan 2024
Contributed by Lukas
We always have a problem to contact regulators to ask them if our strategy is correct. In Europe, you cannot do that with a Notified Body unless you a...
You are not the Physical Manufacturer, can you be MDR certified?
23 Jan 2024
Contributed by Lukas
Who is Adam Isaacs Rar?Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. ...
MEDICA 2023 - InterviewS with Startups, Service Providers, Notified Bodies...
18 Jan 2024
Contributed by Lukas
Medica 2023 was really a great event and I am please to provide you here with a summary and interviews with multiple actors. You'll see that this is s...
WARNING! APPLY TO YOUR NOTIFIED BODY NOW!
16 Jan 2024
Contributed by Lukas
The EU MDR 2017/745 was extended but does this change something for you? Do you need to apply to your notified body later? What can be the promise mad...
Medical Device News – january 2024 Regulatory Update
10 Jan 2024
Contributed by Lukas
MedboardWho is MedboardMedboard: https://www.medboard.com/EU EU Reference laboratories EURLEU Reference laboratories for IVD products: https://eur-le...
Regulatory Maturity Model – Heatmap (MEDICA 2023)
02 Jan 2024
Contributed by Lukas
This presentation was recorded during MEDICA COMPAMED 2023. Stefan Bolleininger from Be on Quality did share with us the information about HEATMAP for...
Life of QA RA Podcasters?
26 Dec 2023
Contributed by Lukas
Easy Medical Device has its podcast and many other Quality and Regulatory Affairs people are also doing podcasting. I have met with Claudia and Jorg w...
Why should you invest in your Regulatory Team?
18 Dec 2023
Contributed by Lukas
Regulatory affairs teams have an outsized impact on business revenue, bringing new products to market quickly, managing registrations and licenses to ...
What is Usability for Medical Devices?
12 Dec 2023
Contributed by Lukas
The Medical Device field is so big that we have a specialist for each type of area. This is like a Surgeon that is specialist of the heart, the orthop...
Medical Device News: December 2023 Regulatory Update
06 Dec 2023
Contributed by Lukas
MedboardMedboard platform Sponsor of the podcast https://www.medboard.com/EUEPSCO Meeting November 30th. 2023 - MDR IVDR device risk of disrupti...
What is the situation regarding digitalization in Medtech?
28 Nov 2023
Contributed by Lukas
Don’t miss this panel discussion that happened during the MEDXD in Berlin (26 and 27 September). Medical Device companies are moving to digitalize t...
How to find your Predicate Device for your 510K Submission?
21 Nov 2023
Contributed by Lukas
The choice of a Predicate Device is important and challenging at the same time. Your predicate device is already on the US market, so all you must do ...
How to CE certify a Calculator, Risk Score…?
14 Nov 2023
Contributed by Lukas
We have a lot of sort of Software as Medical Devices. Today I wanted to ask to Cesare Magri some questions about APIs. First what they are, and can th...
Medical Device News – November 2023 Regulatory Update
09 Nov 2023
Contributed by Lukas
EU:UDI for contact lenses Master-UDI-DI: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302197EUDAMED Roadmap It is a DRAFT: https:...
Validate your Iphone, Samsung Galaxy, Huawei… for your Software
31 Oct 2023
Contributed by Lukas
This MDCG came like evidence but comments on it where more confusion. What exactly was the objective of the MDCG 2023-4. We will try to explain to you...
Afrisummit 2023 Interviews Part 2 – Egypt Situation
24 Oct 2023
Contributed by Lukas
The Afrisummit 2023 in Egypt is over, and I came back with some interviews of some key stakeholders. This is the part 2 where we will focus on the Egy...
Afrisummit 2023 Interviews Part 1
17 Oct 2023
Contributed by Lukas
The Afrisummit 2023 in Egypt is over, and I came back with some interviews of some key stakeholders. First, I have the interview with Morad Ajan - He...
What are some pitfalls to avoid during Software Design?
10 Oct 2023
Contributed by Lukas
More and more companies are starting to develop Software as Medical Devices (SAMD) and in this podcast episode, I have invited Weronika Michaluk to ta...
MEDICAL DEVICE NEWS October 2023 Regulatory Update
04 Oct 2023
Contributed by Lukas
EUManual on Borderline and classification for Medical Devices Update - New entries to the file: https://health.ec.europa.eu/system/files/2023-09/md_bo...
What is the EUDAMED Update?
26 Sep 2023
Contributed by Lukas
EUDAMED is the European Database for Medical Devices. In this episode Richard Houlihan will be my guest and will explain to us the situation regarding...
Interviews on Being The PRRC
19 Sep 2023
Contributed by Lukas
In this second part of this podcast serie on Team-Prrc interviews. we have 3 additional guests. Don't miss the first one where we also got great inter...
Interviews on Being The PRRC
13 Sep 2023
Contributed by Lukas
Within this video you will see 4 interviews on the PRRC role. First one with Piero Costa where we will talk about the role of a PRRC within the differ...
MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update
06 Sep 2023
Contributed by Lukas
EUo MDR and IVDR communication Survey• EU MDR transition• Q&A implementation of MDR extension 2023/607: https://health.ec.europa.eu/system/fil...
How to perform your Cleaning Validation in practice?
29 Aug 2023
Contributed by Lukas
Medical Devices that are reusable should be cleaned. But the user is not a professional of your product so he needs to receive some instruction on how...
What are the Acceptance Criteria for your Clinical Evaluation?
22 Aug 2023
Contributed by Lukas
We all are afraid of one thing. It is to see our Clinical Evaluation rejected by a Notified Body. Why? Because apparently EU MDR is creating a more re...
Why you should automate your Software validation?
15 Aug 2023
Contributed by Lukas
Software validation is key. This is mentioned on different standards, and this is required by the auditors to prove that your software is safe. This i...
Hire your QA RA person with no Budget
08 Aug 2023
Contributed by Lukas
Hiring a new candidate for your team is always a challenge. But how to do that when there is no Budget allocated to it. This is what we will show you ...
Who should be on your Risk Management Dream Team?
01 Aug 2023
Contributed by Lukas
When you look at ISO 13485 or EU MDR or US FDA, they all want to see that you are reducing the risk for your products. But to do that you have to brai...
Artificial Intelligence in the Medical Device Industry
25 Jul 2023
Contributed by Lukas
Artificial Intelligence is the actual hot topic that everyone is talking about. A lot of countries are starting to regulate this technology. But what ...
Validation of Quality Softwares in MedDev
18 Jul 2023
Contributed by Lukas
Have you ever been to an audit and the auditor is asking you to show them the validation of your Quality Management System software. The first reflex ...
How to register Medical Devices in Saudi Arabia
11 Jul 2023
Contributed by Lukas
I am sure that at a certain point, your company will try to market your medical devices in Saudi Arabia. And now you are looking for the information t...
Medical Device News - July 2023 Regulatory Update
04 Jul 2023
Contributed by Lukas
Sponsor Medboard https://www.medboard.com/EUAnnex XVI transitionEU MDR Domino is making more falls. https://eur-lex.europa.eu/legal-content/EN/TXT/?ur...
What should you know on UKCA extension
27 Jun 2023
Contributed by Lukas
Since Brexit happened, there are multiple waves of changes in the UK. First the UK Responsible Person (which is a hybrid of the EU AR and the EU Impor...
How to connect Software dev and QA RA Team
20 Jun 2023
Contributed by Lukas
Software development is really increasing in the Medical Device world and it is maybe important now to discuss about potential gaps that exist between...
The great misunderstanding of EU MDR amendments
13 Jun 2023
Contributed by Lukas
Since March 2023 an extension for EU MDR and IVDR was voted by the EU Commission. This podcast episode will remind you the latest news and also answer...
Medical Device News -June 2023 regulatory update
08 Jun 2023
Contributed by Lukas
Sponsor MedBoard: www.medboard.com EUROPE Notified Body overview: https://health.ec.europa.eu/system/files/2023-05/notifiedbodies_overview_en.pdf E...
How to master regulatory intelligence
30 May 2023
Contributed by Lukas
We all need to keep ourselves up to date. But how to access reliable information and how often should a check be done. This is what we will discuss wi...
What if your Medical Device company goes Bankrupt?
23 May 2023
Contributed by Lukas
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...
Technical Files Inconsistencies identified by Notified Bodies
16 May 2023
Contributed by Lukas
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 lis...
The truth about the UK vs EU situation
09 May 2023
Contributed by Lukas
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 ste...
Medical Device news - May 2023 Regulatory Update
05 May 2023
Contributed by Lukas
•Team-NB Sector Survey 2022 :https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-MD-Sector-Survey-PressRelease-20230411.pdf• MDCG pla...
Transition to Agile for Software as Medical Device
25 Apr 2023
Contributed by Lukas
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...
Prepare your audit like a PRO
18 Apr 2023
Contributed by Lukas
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...
What is a SOUP for your Software Development
11 Apr 2023
Contributed by Lukas
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 Kaest...
Medical Device news for April 2023
04 Apr 2023
Contributed by Lukas
► Podcast page: https://podcast.easymedicaldevice.com/226-2/► Medboard platform: https://www.medboard.com/► MEDBOARD SHOW NOTES LINKS: https://w...
How to perform Risk Management for a Software ?
28 Mar 2023
Contributed by Lukas
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 t...
Proactive Postmarketing Surveillance. What does it mean?
21 Mar 2023
Contributed by Lukas
The EU MDR is requiring more transparency and for the PMS has a lot to play on it. In this episode we will explain to you a difference that is visible...
What you should know about Vigilance Reporting?
14 Mar 2023
Contributed by Lukas
Vigilance Reporting is a process that you should have but that you don’t want to us. In fact not having any vigilance reporting is a sign that you p...
Medical Device News: March 2023 Regulatory Update
08 Mar 2023
Contributed by Lukas
Here is your Regulatory Update for the month of March 2023. Check all the links below- EU MDR 2017/745 extension has been voted: https://www.raps.org/...
Principal at Test labs
28 Feb 2023
Contributed by Lukas
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 Tautv...
SaMD international reach – What to consider?
21 Feb 2023
Contributed by Lukas
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 ma...
Biological Evaluation: Top Big mistakes
14 Feb 2023
Contributed by Lukas
In this podcast episode, Laura and Paul will share with us the big mistakes done by some Medical Device manufacturers when they are considering Biolog...
Medical Device News - February 2023 Regulatory Update
07 Feb 2023
Contributed by Lukas
Here is your Regulatory Update for the month of February 2023. Check all the links below– EU amendment of the EU MDR and IVDR: https://health.ec.eu...
How to do Post-Marketing Surveillance in the US (vs EU)?
31 Jan 2023
Contributed by Lukas
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 ...
How to evaluate Benefit-Risk Ratio for Medical Devices?
24 Jan 2023
Contributed by Lukas
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 ...
Breaking News: EU MDR Extension Proposal is out for consultation
17 Jan 2023
Contributed by Lukas
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...
How to improve the relationship between QA – RA and Marketing?
10 Jan 2023
Contributed by Lukas
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 relations...
Medical Device News: January 2023 Regulatory Update
03 Jan 2023
Contributed by Lukas
EU MDR extensionImplementation of the Medical Device Regulation https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdfProvisional Age...
Grow your LinkedIn Profile with Karandeep Badwal
27 Dec 2022
Contributed by Lukas
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...
EU MDR proposal for extension - Full story with Erik Vollebregt
20 Dec 2022
Contributed by Lukas
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...
MDCG, Team-NB, BVMed & Team-PRRC tell you all about PRRC
13 Dec 2022
Contributed by Lukas
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 list...
Medical Device News - December 2022
06 Dec 2022
Contributed by Lukas
HOT TOPICSEuropeCommon specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745ht...
How to choose the best Sterilisation Method for Medical Devices?
29 Nov 2022
Contributed by Lukas
Sterilization for medical devices is a critical topic. Now when you are developing your Medical Device, you should start by asking which sterilization...
Why Risk Management is important to Medical Device development?
22 Nov 2022
Contributed by Lukas
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 the...
Regulatory Pathway: How to reach the US market [Class II 510k exempt]
15 Nov 2022
Contributed by Lukas
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 ans...
Your Software/IVD clinical report is completely WRONG!
08 Nov 2022
Contributed by Lukas
In this episode, Cesare Magri from 4BetterDevices will explain to us why medical device manufacturers are making mistakes when they try to gather Clin...
Medical Device News - November 2022 Regulatory Update
01 Nov 2022
Contributed by Lukas
This month we will have some updates on:Annex XVIACRAS EventMDCG AgendaCommission Contact updateTeam-NB position paper on Off-label useTeam-NB positio...
Can a PRRC go to Jail? [Elem Ayne]
25 Oct 2022
Contributed by Lukas
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...
How to be MDSAP certified for your Medical Device?
18 Oct 2022
Contributed by Lukas
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 ...
Medical Device News - October 2022 Regulatory Update
11 Oct 2022
Contributed by Lukas
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 E...
EPISODE 200 Celebration - Feedback from EMD Stakeholders
04 Oct 2022
Contributed by Lukas
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 objecti...
How to select your Notified Body and understand the full process?
27 Sep 2022
Contributed by Lukas
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 understan...
How to become the best PRRC ever? [Ronald Boumans]
20 Sep 2022
Contributed by Lukas
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 th...
Why do you need an Initial Importer for the US Market?
13 Sep 2022
Contributed by Lukas
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 ...
Medical Device News - September 2022 Regulatory Update
06 Sep 2022
Contributed by Lukas
Here are the links to the Regulatory UpdatesHOT TOPICEUDAMED Timeline https://health.ec.europa.eu/system/files/2022-07/md_eudamed_timeline_en.pdfEU C...
SaMD or SiMD - How to create a Design Dossier?
30 Aug 2022
Contributed by Lukas
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...
The New Blue Guide - What is the impact to the Medical Device Industry?
23 Aug 2022
Contributed by Lukas
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 revelatio...
Why don't you discontinue correctly your Medical Devices?
16 Aug 2022
Contributed by Lukas
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 ...
When you think “510k” but FDA says “DeNovo” with Spencer Jones
09 Aug 2022
Contributed by Lukas
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 prep...
How to create a Technical Documentation? [EU MDR and IVDR]
02 Aug 2022
Contributed by Lukas
The creation of a Technical File or Technical Documentation for CE marking is really a challenge sometimes. After successfully passing audits with my ...
Do you need a Cleanroom for your Medical Devices? [Philippe Bourbon]
26 Jul 2022
Contributed by Lukas
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...
AI Act vs EU MDR 2017/745 are they compatible? [Erik Vollebregt]
19 Jul 2022
Contributed by Lukas
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 ...
Medtech Europe Forum interviews (MDR, EUDAMED, CER & MECOMED)
12 Jul 2022
Contributed by Lukas
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 int...
Medical Device news - July 2022 Regulatory Update
05 Jul 2022
Contributed by Lukas
This month the Regulatory update will contain a lot regarding Artificial intelligence for medical devices. All the links that are mentioned can be dow...