Shows / Medical Device made Easy Podcast
Episodes
- Medical Device made Easy Podcast
AI Act – What are the challenges for Medical Devices?
You are working with a Software that contains an AI/ML algorithm then you should listen to this podcast episode and understand the requirements of the AI ACT…
- Medical Device made Easy Podcast
Medical Device News, July 2024 Regulatory Update
Medboard EU Germany warns against overregulation of Medical Devices – Is it not too late: https://www.bundestag.de/presse/hib/kurzmeldungen-1006422…
- Medical Device made Easy Podcast
How to submit your AI/ML SAMD the right way?
You don’t know what a regulator will say when seeing your AI/ML Software, then listen to this episode. Richie Christian will explain the important elements…
- Medical Device made Easy Podcast
AFNOR – How is a Notified Body designated?
If you are looking for selling your medical devices in Europe, you will then maybe need a Notified Body unless your product is class I. In this episode, we…
- Medical Device made Easy Podcast
Cleaning Validation – How to select the worst case?
Have you ever had to deal with Cleaning Validation. If yes than you know the pain to select the instruments and group them and for each group find a worst…
- Medical Device made Easy Podcast
Medical Device News June 2024 Regulatory Update
EUROPE EU MDR 26 May 2024 – Was there any apocalypse: France: https://ansm.sante.fr/actualites/reglement-europeen-relatif-aux-dispositifs-medicaux-fin-de-…
- Medical Device made Easy Podcast
Summative Evaluation – Common mistakes
I am sure that when we talk about usability, you are not really sure what should be done. Usually we are also following a standard for that which is IEC 62366…
- Medical Device made Easy Podcast
Are you more Corrections or Corrective Actions or Preventive Actions?
Do you have to manage complaints, CAPA, Non-conformances, audits, management reviews… for your company. Then you need to put in place actions. Today we will…
- Medical Device made Easy Podcast
How to select and evaluate your Contract Manufacturer?
Medical Device manufacturers can also involve third party companies to manufacture their devices. We call them Contract Manufacturers. But they are only your…
- Medical Device made Easy Podcast
Quality Field Service for Medical Devices
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 Field…
- Medical Device made Easy Podcast
Medical Device NewsMAY 2024 Regulatory Update
EU Notified Bodies TUV SUD Denmark under MDR –Welcome to the Brother or Sister…
- Medical Device made Easy Podcast
Why and how to build a Quality Culture?
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 one. We…
- Medical Device made Easy Podcast
What is the impact of AI Act on Medical Devices?
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 Quality or…
- Medical Device made Easy Podcast
Radiation Sterilisation Master File (ISO 11137 & 11607)
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 life to…
- Medical Device made Easy Podcast
Medical Device News April 2024 Regulatory Update
Sponsor: Medboard: https://www.medboard.com/ EU MDR and IVDR national languages update – France accepts English MDR…
- Medical Device made Easy Podcast
How to benefit from Surveys to build Clinical Evidence?
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…
- Medical Device made Easy Podcast
How to do Postmarketing Surveillance the right way?
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 want to…
- Medical Device made Easy Podcast
Learn more about FDA QMSR alignment with ISO 13485
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 QMS?…
- Medical Device made Easy Podcast
Medical Device News March 2024 Regulatory Update
EU EU proposal to prevent shortage – And other things: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses…
- Medical Device made Easy Podcast
New EU Proposal – EUDAMED, IVDR & Shortage
In January 29th, 2024, the EU Commission issued a Proposal that discuss mainly the shortage of Medical Devices, the EUDAMED availability and the IVDR…
- Medical Device made Easy Podcast
Will EtO gaz become a Medical Device?
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 potential…
- Medical Device made Easy Podcast
How to get your interview prepared?
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 the…
- Medical Device made Easy Podcast
Medical Device News february 2024 Regulatory Update
EU Transition to the IVDR and EUDAMED Roll Out -An extension? Never !!!!!: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-proposal.PDF Measures…
- Medical Device made Easy Podcast
Why you should use Pre-Submission or Q-Sub with FDA?
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 apply with…
- Medical Device made Easy Podcast
You are not the Physical Manufacturer, can you be MDR certified?
Who is Adam Isaacs Rae? Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth…
- Medical Device made Easy Podcast
MEDICA 2023 – InterviewS with Startups, Service Providers, Notified Bodies…
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 so…
- Medical Device made Easy Podcast
WARNING! APPLY TO YOUR NOTIFIED BODY NOW!
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 made by your…
- Medical Device made Easy Podcast
Medical Device News – january 2024 Regulatory Update
Medboard Who is Medboard Medboard: https://www.medboard.com/ EU EU Reference laboratories EURL EU Reference laboratories for IVD products…
- Medical Device made Easy Podcast
Regulatory Maturity Model – Heatmap (MEDICA 2023)
This presentation was recorded during MEDICA COMPAMED 2023. Stefan Bolleininger from Be on Quality did share with us the information about HEATMAP for…
- Medical Device made Easy Podcast
Life of QA RA Podcasters?
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 who are…
- Medical Device made Easy Podcast
Why should you invest in your Regulatory Team?
Regulatory affairs teams have an outsized impact on business revenue, bringing new products to market quickly, managing registrations and licenses to keep…
- Medical Device made Easy Podcast
What is Usability for Medical Devices?
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 orthopaedic……
- Medical Device made Easy Podcast
Medical Device News: December 2023 Regulatory Update
Medboard Medboard platform Sponsor of the podcast https://www.medboard.com/ EU EPSCO Meeting November 30th. 2023 – MDR IVDR device risk of disruption…
- Medical Device made Easy Podcast
What is the situation regarding digitalization in Medtech?
Don’t miss this panel discussion that happened during the MEDXD in Berlin (26 and 27 September). Medical Device companies are moving to digitalize their…
- Medical Device made Easy Podcast
How to find your Predicate Device for your 510K Submission?
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 is select…
- Medical Device made Easy Podcast
How to CE certify a Calculator, Risk Score…?
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 they be a…
- Medical Device made Easy Podcast
Medical Device News – November 2023 Regulatory Update
EU: UDI for contact lenses Master-UDI-DI: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302197 EUDAMED Roadmap It is a DRAFT…
- Medical Device made Easy Podcast
Validate your Iphone, Samsung Galaxy, Huawei… for your Software
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 on this…
- Medical Device made Easy Podcast
Afrisummit 2023 Interviews Part 2 – Egypt Situation
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 Egypt…
- Medical Device made Easy Podcast
Afrisummit 2023 Interviews Part 1
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 – Head…
- Medical Device made Easy Podcast
What are some pitfalls to avoid during Software Design?
More and more companies are starting to develop Software as Medical Devices (SAMD) and in this podcast episode, I have invited Weronika Michaluk to talk to us…
- Medical Device made Easy Podcast
October 2023 Regulatory Update
EU Manual on Borderline and classification for Medical Devices Update – New entries to the file…
- Medical Device made Easy Podcast
What is the EUDAMED Updates?
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…
- Medical Device made Easy Podcast
Interviews on Being The PRRC (Part 2)
In this second part of this podcast series on Team-Prrc interviews. we have 3 additional guests. Don’t miss the first one where we also got great…
- Medical Device made Easy Podcast
Interviews on Being The PRRC
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 different…
- Medical Device made Easy Podcast
MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update
EU MDR and IVDR communication Survey: https://ec.europa.eu/eusurvey/runner/MDR_and_IVDR_Communication_Survey EU MDR transition Q&A implementation of MDR…
- Medical Device made Easy Podcast
How to perform your Cleaning Validation in practice?
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 to clean…
- Medical Device made Easy Podcast
What are the Acceptance Criteria for your Clinical Evaluation?
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 restrictive…
- Medical Device made Easy Podcast
Why you should automate your Software validation?
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 is valid…
- Medical Device made Easy Podcast
Hire your QA RA person with no Budget
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 in the…
- Medical Device made Easy Podcast
Who should be on your Risk Management Dream Team?
https://youtu.be/QiYehhfxbwg 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…
- Medical Device made Easy Podcast
Artificial Intelligence in the Medical Device Industry
Artificial Intelligence is the actual hot topic that everyone is talking about. A lot of countries are starting to regulate this technology. But what are we…
- Medical Device made Easy Podcast
Validation of Quality Software in Medical Devices
https://youtu.be/wQvuFyROLv8 Have you ever been to an audit and the auditor is asking you to show them the validation of your Quality Management System…
- Medical Device made Easy Podcast
How to register Medical Devices in Saudi Arabia?
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 that will…
- Medical Device made Easy Podcast
Medical Device News – July 2023 Regulatory Update
Sponsor Medboard https://www.medboard.com/ EU Annex XVI transition https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1194 Cybersecurity and…
- Medical Device made Easy Podcast
What should you know on UKCA extension
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 Importer)…
- Medical Device made Easy Podcast
How to connect Software dev and QA RA Team
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…
- Medical Device made Easy Podcast
The great misunderstanding of EU MDR amendments
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 some…
- Medical Device made Easy Podcast
Medical Device News -June 2023 regulatory update
Sponsor MedBoard: www.medboard.com EUROPE Notified Body overview: https://health.ec.europa.eu/system/files/2023-05/notifiedbodies_overview_en.pdf EU MDR and…
- Medical Device made Easy Podcast
How to master Regulatory Intelligence?
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 with Ivan…