Best Meddevices Podcasts (2024)

1
How to register your Medical Device in the UAE?

2h ago

—

Registration of Medical Devices can be complicated. But here we will share with you the process for the United Arab Emirate where the famous city of Dubai is located. Ahmed Hendawy from Registitute is helping us to understand this process and he confirms that it is really simple. So no way that you miss this. Who is Ahmed Hendawy? Ahmed is an estee…

1
EU Battery Regulation – How to be ready?

8d ago

—

More and more regulations have to be applied in parallel of the EU MDR and the one of the EU Battery Regulation is not an exception. Erik Vollebregt from Axon Lawyers will be explaining to us what are these additional requirements. He will also confirm that Notified Bodies can ask you questions about it and finally he will share some key timelines …

1
AI Act – What are the challenges for Medical Devices?

14d ago

—

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 to your medical device. Fabien Roy, lawyer will explain to us what are the challenges that he has identified for medical device manufacturers working with Artificial Intelligence. Who is Fabie…

1
Medical Device News, July 2024 Regulatory Update

18d ago

—

Medboard EU Germany warns against overregulation of Medical Devices – Is it not too late: https://www.bundestag.de/presse/hib/kurzmeldungen-1006422 Title: MDR and IVDR next steps – Subtitle: Erik Vollebregt points: https://medicaldeviceslegal.com/2024/06/04/the-german-angle/ MDCG 2022-13 Rev1 – Extension of the scope of designations: https://health…

1
How to submit your AI/ML SAMD the right way?

28d ago

—

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 that you should take care off before to submit your dossier to your Notified Body or your Competent Authority. So enjoy. Who is Richie Christian? Richie Christian has more than 10 years of exper…

1
AFNOR – How is a Notified Body designated?

1M ago

—

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 talk with Thomas Lommatzsch about the process of designation and why it is so difficult. We will also cover some questions regarding the auditors, the costs, the audit by the competent authoriti…

1
Cleaning Validation – How to select the worst case?

1M ago

—

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 case. On this episode, we tell you how this should be working so you can guarantee to provide clean products and clean instructions to your customers. Who is Heena Thakkar? Heena Thakkar is a reg…

1
Medical Device News June 2024 Regulatory Update

2M ago

—

EUROPE EU MDR 26 May 2024 – Was there any apocalypse: France: https://ansm.sante.fr/actualites/reglement-europeen-relatif-aux-dispositifs-medicaux-fin-de-la-periode-de-transition Netherland: https://www.igj.nl/zorgsectoren/medische-technologie/nieuws/2024/05/23/fabrikanten-van-medische-hulpmiddelen-moeten-uiterlijk-26-mei-een-aanvraag-hebben-ingedi…

1
AI in Healthcare Human Factors: Ready or Not, Here it Comes, Can We Hide? (ft. Kate Preston and Barry Kirby) 1:26:19

2M ago1:26:19

1:26:19

Join us in our latest episode of Safe and Effective, where we welcome our new friend Kate Preston and our Human Factors Cast family member Barry Kirby to have a chat with us about AI in Healthcare and Medical Device and Development and HumanFactors and its current and future challenges, as well as the implications for such. AI in medical device dev…

1
Summative Evaluation – Common mistakes

2M ago

—

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. On this episode, Amandine Broussier will specifically focus on one part of usability which is the Summative Evaluation. She will explain what this is and when it should be done. So listen to…

1
Are you more Corrections or Corrective Actions or Preventive Actions?

2M ago

—

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 explain to you with Vincent Cafiso what are Correction, Corrective Actions and Preventive Actions. Who is Vincent Cafiso Named as one of MD+DI’s 24 Medtech Voices to Follow in 2024, Vincent Caf…

1
How to select and evaluate your Contract Manufacturer?

2M ago

—

Medical Device manufacturers can also involve third party companies to manufacture their devices. We call them Contract Manufacturers. But they are only your supplier and not the legal manufacturer of the product. So now the question is how to select them and also how to handle them. Let’s find that out with Keith Smith from Vonco Who is Keith Smit…

1
Quality Field Service for Medical Devices

3M ago

—

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 Service Engineer can help Quality Department to have a better operation. Collect machine performance, train technicians, identify issues. Michael will also talk about Zuper which is a FSM softwar…

1
Medical Device NewsMAY 2024 Regulatory Update

3M ago

—

EU Notified Bodies TUV SUD Denmark under MDR –Welcome to the Brother or Sister: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=150a0abbc0d4397086d648963fc940a321e02c11&group=NOTIFICATION&download=true AFNOR 46th NB under MDR –Finally a second one for France: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies…

1
Why and how to build a Quality Culture?

3M ago

—

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 will review the description of a quality culture and how to build it. But also if this is required by a regulation and how you can align it with your compliance duties. Check this and share it…

1
What is the impact of AI Act on Medical Devices?

3M ago

—

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 Regulatory affairs activities. Erik Vollebregt, from Axon Lawyers will tell us what we should understand with this new legislation and what are the consequences for the Medical Device commun…

1
Radiation Sterilisation Master File (ISO 11137 & 11607)

4M ago

—

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 the product. So Adam Isaacs Rae will provide you with the information on Radiation Sterilization requirements. Standards, guidelines, pitfalls. All this will help you remain compliant. Who is …

1
Medical Device News April 2024 Regulatory Update

4M ago

—

Sponsor: Medboard: https://www.medboard.com/ EU MDR and IVDR national languages update – France accepts English MDR: https://health.ec.europa.eu/document/download/aa9760e3-c864-4173-8b16-d790dac66d74_en?filename=md_sector_lang-req-table-mdr.pdf IVDR: https://health.ec.europa.eu/document/download/1e312d8f-8b34-45da-a5fa-1918ba618aca_en?filename=md_s…

1
How to benefit from Surveys to build Clinical Evidence?

4M ago

—

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 this right and what you should be careful on. So listen to Cesare Magri from 4BetterDevices who will tell us more about surveys in the Medical Device field. Who is Cesare Magri? Cesare has a…

1
Desperately Seeking: MedDev Human Factors Use Error Classification System (ft. Bert Boquet) 1:11:08

4M ago1:11:08

1:11:08

Join us in our latest episode of Safe and Effective, where we welcome back our good friend Dr. Albert Boquet to talk about using an existing framework, such as HFACS, to develop a unified use error classification system and database to add as a tool to the human factors engineering process in the medical device and combination product (development)…

1
How to do Postmarketing Surveillance the right way?

4M ago

—

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 see and how you can avoid some mistakes that are always identified. Who is Steve Curran? Dr Steve Curran has over 20 years experience in the medical device industry both as an engineer and le…

1
Learn more about FDA QMSR alignment with ISO 13485

5M ago

—

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? Will you need to go through another audit or inspection? Is this really a revolution? Naveen Agarwal from Exceed will answer this question. So don’t miss this episode to know more about QMSR. Wh…

1
Medical Device News March 2024 Regulatory Update

5M ago

—

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-new-measures-to-help-prevent-shortages/ Notified Body Survey – Interesting statistics: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_…

1
New EU Proposal – EUDAMED, IVDR & Shortage

5M ago

—

In January 29th, 2024, the EU Commission issued a Proposal that discuss mainly the shortage of Medical Devices, the EUDAMED availability and the IVDR transition periods. So apparently this is urgent and needed to avoid shortage. Let’s ask Erik Vollebregt what he thinks about it. Will this really help and when will this become a law as it is only a …

1
Will EtO gaz become a Medical Device?

5M ago

—

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 change that will happen and we want to alert you about that. Christina Ziegenberg from BVMed is answering my questions and will explain to us the situation. So don’t miss this episode. Who i…

1
How to get your interview prepared?

6M ago

—

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 expert in recruitment for Medical Devices Elena Kyria from Elemed. She will give you all the hints, tips to make your interview a success. So don’t miss this episode and don’t forget to raise you…

1
Medical Device News february 2024 Regulatory Update

6M ago

—

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: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_24_346/IP_24_346_EN.pdf Question and Answers: https://ec.europa.eu/commission/presscorner/api/files/document/print/…

1
Why you should use Pre-Submission or Q-Sub with FDA?

6M ago

—

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 one first and they cannot provide you with advice but just agree or disagree on your plan. Is it the same with the FDA. They have a specific pathway called Q-sub or Pre-Submission and you’ll…

1
You are not the Physical Manufacturer, can you be MDR certified?

6M ago

—

Who is Adam Isaacs Rae? Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stre…

1
Women in (Med)Tech in HF/UX (ft. Rebecca Grier) 1:21:48

6M ago1:21:48

1:21:48

Join us in our latest ‘Let’s Get Real’ episode of Safe and Effective, where we delve into a nuanced and multi-faceted conversation with Rebecca Grier, a behavioral science expert in human factors and UX in the tech industry, discussing the broader issues of inequities and inequalities faced by women in the workplace, with a focus on behavioral scie…

1
MEDICA 2023 – InterviewS with Startups, Service Providers, Notified Bodies…

6M ago

—

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 diverse. We met with Startups, Service Providers, Notified Bodies and asked them the questions you would like to ask. So don’t miss this opportunity first to understand what is MEDICA and second to …

1
WARNING! APPLY TO YOUR NOTIFIED BODY NOW!

7M ago

—

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 Notified Body? Can they advice you? Pritam from TÜV SÜD will be answering my question without any taboo. So don’t hesitate also to go to the show notes and see his details as at the end of t…

1
Medical Device News – january 2024 Regulatory Update

7M ago

—

Medboard Who is Medboard Medboard: https://www.medboard.com/ EU EU Reference laboratories EURL EU Reference laboratories for IVD products: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302713 Article : https://health.ec.europa.eu/latest-updates/designation-eu-reference-laboratories-high-risk-vitro-diagnostic-medical-devices-2023-1…

1
Regulatory Maturity Model – Heatmap (MEDICA 2023)

7M ago

—

This presentation was recorded during MEDICA COMPAMED 2023. Stefan Bolleininger from Be on Quality did share with us the information about HEATMAP for Regulatory Affairs. The idea is mainly to be able to improve the visualisation of a certain state of your department or project. There will be the collection of data, the scoring, then the creation o…

1
The Human (Factor) in the Neurodivergent Experience (ft. Nick Roome) 1:37:37

7M ago1:37:37

1:37:37

In today’s episode of Safe and Effective we are featuring an excerpt of the previously recorded Human Factors Cast show in which Nick Roome and our host Heidi Mehrzad shared their personal experiences living with ADHD and AuDHD/ASD and discussed the various ways in which their neurodiversity impacts their lives. From professional to personal relati…

1
Life of QA RA Podcasters?

7M ago

—

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 also having a podcast and we reviewed our experience and encouraged people to also start their podcast. Check our experience and learn from it. Who is Monir El Azzouzi? Monir El Azzouzi is the …

1
Why should you invest in your Regulatory Team?

7M ago

—

Regulatory affairs teams have an outsized impact on business revenue, bringing new products to market quickly, managing registrations and licenses to keep products on the market, and staying updated on changing standards and regulations that might impact market clearance. Yet most regulatory affairs teams are treated primarily as operational cost-c…

1
What is Usability for Medical Devices?

8M ago

—

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… Here we have with us a specialist for Usability, and this is really a big filed that you need to understand. IEC 62366 is a standard that is important to know as all devices that have a user in…

1
Medical Device News: December 2023 Regulatory Update

8M ago

—

Medboard Medboard platform Sponsor of the podcast https://www.medboard.com/ EU EPSCO Meeting November 30th. 2023 – MDR IVDR device risk of disruption: https://data.consilium.europa.eu/doc/document/ST-15385-2023-REV-2/x/pdf Survey on Medical Devices – Study supporting the monitoring of the availability of Medical Devices on the EU Market. Informatio…

1
What is the situation regarding digitalization in Medtech?

8M ago

—

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 processes and MDKU association did create the MEDXD conference where the discussions from multiple companies helped to understand the status. Monir El Azzouzi moderated this panel and asked questio…

1
How to find your Predicate Device for your 510K Submission?

8M ago

—

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 it and confirm that your device is the same as the predicate and Bingo, you can register your product in the US. But this is not as simple as that. Beat Keller from imt in Switzerland will s…

1
How to CE certify a Calculator, Risk Score…?

9M ago

—

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. He will also give us some advice on what to do if your API is really a medical device. So stay tuned. Who is Cesare Magri? Cesare Magri is the founder and CEO of 4BetterDevices…

1
Medical Device News – November 2023 Regulatory Update

9M ago

—

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: https://health.ec.europa.eu/system/files/2023-10/md_eudamed_roadmap_en.pdf MDCG 2023-4 guidance – Validate the combination with hardware https://health.ec.europa.eu/system/files/2023-10/md_mdcg_2023-4_softw…

1
Validate your Iphone, Samsung Galaxy, Huawei… for your Software

9M ago

—

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 podcast with Erik Vollebregt from Axon Lawyers. Who is Erik Vollebregt? Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth…

1
Afrisummit 2023 Interviews Part 2 – Egypt Situation

9M ago

—

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 situation. Check Part 1 for the first interviews with (https://podcast.easymedicaldevice.com/254-2/): – Morad Ajan – Head of Medical Device Unit at Direction du Médicament et de la Pharmacie (DMP) …

1
Failure as a Path to Innovation and Resilient Outcomes (ft. Christy Harper) 1:13:02

10M ago1:13:02

1:13:02

Join us in our latest episode of Safe and Effective, in which we launch our newest segment ‘Let’s Get Real’ - where we drop all filters and stop masking and get real about special and sometimes sensitive topics and issues. In our first ever Let’s Get Real segment we talk with Christy Harper, usability expert and co-founder of End-to-End User Resear…

1
Afrisummit 2023 Interviews Part 1

10M ago

—

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 of Medical Device Unit at Direction du Médicament et de la Pharmacie (DMP) – Morocco. We reviewed the Quality and Regulatory situation of Morocco and learned a lot of good information about progress…

1
What are some pitfalls to avoid during Software Design?

10M ago

—

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 about some pitfalls that you need to avoid. Weronika will talk about: – Risk Management – Usability – Documentation – Expertise – Interoperability and scalability – Cybersecurity. So don’t mi…

1
October 2023 Regulatory Update

10M ago

—

EU Manual on Borderline and classification for Medical Devices Update – New entries to the file: https://health.ec.europa.eu/system/files/2023-09/md_borderline_manual_en.pdf Q&A on Annex XVI Products – Check transition timeline: https://health.ec.europa.eu/system/files/2023-09/md_new-reg_annex-xvi_q-n-a_transition-prov.pdf Italy: Custom-made medica…

1
A Collaborative Approach Between Clinical and HF (ft. Helene Quie) 1:04:10

10M ago1:04:10

1:04:10

Join us in our fourth episode of Safe and Effective, where we dive deep with Helene Quie, regulatory and clinical expert, and founder and CEO of Qmed Consulting A/S in Copenhagen, Denmark. Together, we explore the pivotal role of a collaborative approach between clinical and human factors teams in order to align with regulatory requirements as well…

Podcasts Worth a Listen

Meddevices Podcasts

Podcasts Worth a Listen

Quick Reference Guide