Лучшие подкасты про Meddevices (2024)

1
Medical Device News November 2024 Regulatory Update

1d ago

—

Medboard https://www.medboard.com/ EU Urgent update needed – EU MDR and IVDR: https://www.europarl.europa.eu/doceo/document/TA-10-2024-0028_EN.pdf HMA communication: https://www.hma.eu/fileadmin/dateien/Medical_Devices/CGMD/241018_Letter.pdf EU Commission Newsletter – What are the hot news: https://ec.europa.eu/newsroom/sante/newsletter-archives/56…

1
What does a strategy for regulatory compliance looks like?

9d ago

—

In this episode, Adam Isaacs Rae will help us shape your Regulatory Compliance Strategy. This is a requirement of the EU MDR and IVDR but it doesn’t provide much information. So, let’s review that together. Who is Adam Isaacs Rar? Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsm…

1
What are the TOP 3 issues on CAPAs?

15d ago

—

in this episode, Georg Digel will help use solve 3 major problems with our CAPAs. He will tell you what these problems within your Quality Management System are and propose some solution. We will also talk about the education of the team. Who is Georg Digel? I’ve reviewed too many Medical Device CAPAs over the last 10 years. I think I’ve seen almos…

1
Starting from Scratch: Integrating Agile Mode into HF/UX Research Operations (ft. Nick Roome) 1:29:06

16d ago1:29:06

1:29:06

Join us in our latest episode of Safe and Effective, where we dive headfirst into the wild and wonderful world of integrating agile development methodologies into HF (Human Factors) and UX (User Experience) research operations, with none other than our friend, favorite human, and podcast bestie, Nick Roome. We kick things off by tackling age-old qu…

1
Medical Device News, October 2024 Regulatory Update

23d ago

—

Medboard: https://www.medboard.com/ EUROPE TEAM NB – Code of Conduct for NB – Version 5: https://www.team-nb.org/wp-content/uploads/2024/09/PressRelease-CoC-20240916.pdf TEAM NB – IVDR Transition – Transition to the implementation of Class D oversight by EURLs: https://www.team-nb.org/wp-content/uploads/2024/10/PressRelease-ClassD-20241001.pdf MDCG…

1
How to select the best plastic for your Medical Device?

30d ago

—

In this episode, Lucas Pianegonda will help us to select the right material for your medical device and also answer questions that you maybe would love to hear his answer. We will also talk about sustainability for plastics. So check this. Who is Lucas Pianegonda? Lucas Pianegonda is an expert for medical grade plastics, material testing and materi…

1
UK vs EU vs US – How to switch to another region easily?

1M ago

—

In this episode, Claire Dyson will give us the recipe to launch correctly your Medical Device when you go abroad and for that we will take the example of EU and US. Who is Claire Dyson? Who is Claire Dyson? Claire Dyson began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery …

1
How to do a PMCF Literature Search for Medical Devices?

2M ago

—

In this episode, Cesare Magri will try to improve our skills on PMCF literature search. We will investigate on the misconceptions and what people should make to do it right. Who is Cesare Magri? Cesare Magri is the founder and CEO of 4BetterDevices GmbH. He and his team of medical doctors and biostatisticians assist medical device and in-vitro diag…

1
Medical Device News, Septembre 2024 Regulatory Update

2M ago

—

EU e-IFU for medical devices – Consultation ongoing: https://ec.europa.eu/eusurvey/runner/Survey_eIFUs_medicaldevices_2024?surveylanguage=EN MDR Transition period – Visual timeline: https://health.ec.europa.eu/document/download/06bb3982-dc01-46aa-95af-d8833c9fcb21_en?filename=timeline_mdr_en.pdf Implementing Act IVDR Common specifiaction – Consulta…

1
How to use AI GPT for your Quality and Regulatory work?

2M ago

—

In this episode, Martin King will share with us his practice of AI in the context of Quality and Regulatory affairs for medical devices. This will explain to you some best practices to maintain to avoid some pitfalls. Who is Martin King? Martin Cranston King, a Swiss consultant working with medical devices, in vitro diagnostics (IVD), and pharmaceu…

1
How to go from Zero to Hero in Medical Devices?

2M ago

—

In this episode, Stephen O’Rourke that was not working within the Medical Device industry will share with us is journey from Zero knowledge in the field to running projects. Listen to his journey in case you are also willing to breakthrough the medical device field. Who is Stephen O’Rourke? Stephen O’Rourke, based in Berlin, Germany, is a seasoned …

1
Manage the Transfer/Renewal/Surveillance/Change of your CE certificate

2M ago

—

In this episode, I have invited Ralf Gansel to help us understand the process for Certification of your product and what is the lifecycle for it. We’ll discuss about Transfer or certificates, or notification of changes or why there is a renewal and not continuous surveillance… Who is Ralf Gansel? With over a decade of experience in the medical heal…

1
How to use Harmonized Standards for Medical Devices?

3M ago

—

Medical Devices should follow some standards but if these standards are harmonized this brings them to another level. This will be a great discussion with Beat Keller on how to use them correctly. Who is Beat Keller? Beat Keller is the founder and Managing Director of SMDC which supports medical devices to bring compliant medical devices on market …

1
IVDR Class D – Lesson learned from Notified Bodies

3M ago

—

The EU IVDR is in place and we will focus on this episode on Class D devices. Andreas Stange will explain to us what TÜV SÜD learned from the 100th class D certificates they issued. We will also review the timeline for IVDR and explain the next deadline which is in October. So be aware of it now. Who is Andreas Stange? Dr. Andreas F. Stange is a vi…

1
EU MDR Major update: Interruption or Discontinuation of supply!

3M ago

—

The EU MDR is still not stable. There are still updates ongoing so stay tuned and listen to Erik Vollebregt explaining the Article 10a that will be integrated to the EU MDR where medical device manufacturers have to inform about interruption of supply. So what will be the requirements and what should you do. Listen to it to know more. Who is Erik V…

1
How to register your Medical Device in the UAE?

3M 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?

4M ago

—

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

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

4M 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

4M 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?

4M 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?

5M 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?

5M 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

5M 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

5M 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

5M 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?

6M 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?

6M 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

6M 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

6M 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?

6M 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?

7M 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)

7M 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

7M 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?

7M 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

7M 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?

8M 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

8M 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

8M 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

8M 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?

9M 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?

9M 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

9M 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?

9M 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?

9M 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

10M 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…

10M 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!

10M 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

10M 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)

10M 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

10M 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…

Подкасты, которые стоит послушать

Подкасты на тему Meddevices

Подкасты, которые стоит послушать

Краткое руководство