Best MDR Podcasts (2024)

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Treating persons with HIV who are heavily treatment-experienced or have MDR HIV-1 - Ep 138 25:26

2d ago25:26

25:26

A discussion with the lead authors of the new consensus recommendations on the use of novel antiretrovirals in persons with HIV who are heavily treatment-experienced and/or have multidrug-resistant HIV-1. Full text of the manuscript is available Open Access at: https://accpjournals.onlinelibrary.wiley.com/doi/10.1002/phar.2914…

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AFNOR – How is a Notified Body designated?

3d ago

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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
Episode 184 | Matt Iorio, Senior Manager Clinical Affairs and Data Analytics at Neuros Medical | The Importance of Clinical Data and How to Collect It 39:03

3d ago39:03

39:03

In this episode, Matt Iorio at Neuros Medical and Duane Mancini discuss his background in the Medtech space, the collection of clinical data, the importance of clinical data for regulatory and commercial purposes, and so much more.

1
Impact of internal medicine pharmacists on antimicrobial stewardship - Ep 137 11:52

8d ago11:52

11:52

All the internal medicine pharmacists are doing it, but what are they doing and is it working? Learn about this group's impact on antimicrobial stewardship. Full text of the manuscript is available at: https://accpjournals.onlinelibrary.wiley.com/doi/10.1002/jac5.1926.

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Cleaning Validation – How to select the worst case?

10d ago

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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
Episode 183 | Rick Geoffrion, President & CEO at Cyrano Therapeutics and Chip Hance, CEO at Regatta Medical | The History and Importance of the Early Feasibility Studies (EFS) Program at the FDA 38:11

10d ago38:11

38:11

In this episode, Rick Geoffrion at Cyrano Therapeutics and Chip Hance at Regatta Medical and Duane Mancini discuss history of the Early Feasibility Studies (EFS) Program at the @FDA, the importance of it, how @MDIC supported mission and so much more.

1
Medical Device News June 2024 Regulatory Update

14d ago

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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
Episode 182 | Andy Fish, CEO & President and Joe Sapiente, Senior Vice President at Medical Device Innovation Consortium (MDIC) | Facilitating Discussions between Government and Industry 42:32

17d ago42:32

42:32

In this episode, Andrew Fish and Joseph Sapiente at Medical Device Innovation Consortium (MDIC) and Duane Mancini discuss the mission of MDIC, the various initiatives and programs, how to engage MDIC and so much more.

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MTBVAC - one of the most promising new TB Vaccines with Dr Carlos Martín Montañés 42:58

20d ago42:58

42:58

Today we discuss the MTBVAC with Dr Montañés. MTBVAC is an attenuated vaccine from a human mycobacterial isolate which has just progressed to a phase 3 trial and shown very promising results in the phase 2 study. Dr Montañés has been involved in this project for over a decade and has an incredible insight into the development and promise of this va…

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FSSC 24000 Series - Part 1: Exploring the New Social Management System Certification 12:22

21d ago12:22

12:22

Listen to the 1st episode of our Assurance in Action podcast series on FSSC 24000. We're thrilled to welcome our special guest, Jacqueline Southee the North American Representative at Foundation FSSC. In this episode, we explore the key features and benefits of implementing an FSSC 24000 social management system, and how it can significantly enhanc…

1
Summative Evaluation – Common mistakes

24d ago

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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
Episode 181 | Brittani Ritchie, Consultant, Operations at Project Medtech | Making Quality a Part of Company Culture 34:00

24d ago34:00

34:00

In this episode, Brittani Ritchie at Project Medtech and Duane Mancini discuss her background in the Medtech industry, making quality a part of your culture, what to expect in an FDA audit and so much more.

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

1M ago

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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
Countdown to Infosecurity Europe 2024 19:02

1M ago19:02

19:02

Infosecurity Europe is a cornerstone event in the cybersecurity industry. It brings together a diverse array of cybersecurity services and professionals for three days of unparalleled learning, exploration, and networking. At its essence, the event is committed to delivering indispensable value to its attendees through meticulously crafted themes a…

1
How to select and evaluate your Contract Manufacturer?

1M ago

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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
A Conversation with Vistatec's Life Science In-Focus Podcast 21:22

1M ago21:22

21:22

The good folks at Vistatec invited me to participate in their Life Science In-Focus podcast last month, where host Karen Tkaczyk and I chatted about the intricacies of regulatory affairs within the life sciences.We also discussed just how I ended up in the field, and the many challenges companies face when choosing regulatory pathways in the United…

1
Navigating the Medical Device Regulation (MDR) Transition 15:56

1M ago15:56

15:56

In this episode, we're counting down to a shift in the medical device industry: the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR). Our expert, Curtis Riley, Head of Notified Body at Intertek Medical Notified Body – Business Assurance, discusses the main challenges for manufacturers, explains the key diffe…

1
Dosing warfarin in a postpartum woman who’s breastfeeding - Ep 136 11:08

1M ago11:08

11:08

Dr. Ellen Uppuluri provides perspective on anticoagulation management in postpartum women based on a case report and the research surrounding it. Full text of the manuscript is available at: https://accpjournals.onlinelibrary.wiley.com/doi/10.1002/phar.2917.

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Disco Dice - The Sputnik Disko - Session 260 2:00:05

1M ago2:00:05

2:00:05

Best Discohouse and Clubgrooves by Disco Dice 2hours live on Air on Radio MDR Sputnik (Germany) DISCO DICE / Dj Team - Germany www.discodice.de Mgmt: Marco Benitz bkng: www.dnrg-mgmt.de mobil: +49 177 2504210 bookings: marco@dnrg-mgmt.de Instagram: https://www.instagram.com/discodicedj Facebook: https://www.facebook.com/discodicedj Bandcamp: https:…

1
Quality Field Service for Medical Devices

1M ago

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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

2M ago

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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
VAT update with Jane Deeks 35:24

2M ago35:24

35:24

We are delighted to welcome back Jane Deeks for this episode for an overview of what you should be looking out for on any given transaction. The budget saw an increased VAT registration threshold to £90k. Watch out for the running 12 month totals; make sure you comply with the 'look forward test'; recovery of VAT on a development; criteria for VAT …

1
TB Contact Tracing and Building Research in TB with Prof Philip Hill 30:13

2M ago30:13

30:13

Prof Greg Fox speaks with Prof Philip Hill about TB household contact tracing and building research capacity in TB. Prof Hill is an ID specialist and public health physician who did his PhD in TB Epidemiology. He is the current McAuley Chair in International Health as well as being Founding Direction & Co-Director of the Centre for International He…

1
Episode 180 | Charles Allan, Chief Executive Officer at MY01 | Lessons Learned So Far from a Medtech Startup CEO 36:45

2M ago36:45

36:45

In this episode, Charles Allan at MY01 and Duane Mancini discuss his background in the Medtech industry, what MY01 is working on, the Medtech Innovator program, focus on collecting clinical data for commercialization support, fundraising strategies as you advance rounds, the Canadian Medtech ecosystem and so much more.…

1
Driving Quality: Navigating APQP/CP Deployment in Automotive Supply Chains 12:25

2M ago12:25

12:25

Welcome to another episode of our Intertek’s Assurance in Action podcast! In this episode, our expert, Carmine Liuzzi discusses the challenges and best practices for effective Advanced Product Quality Planning and Control Plan (CP) deployment in automotive supply organizations. Stream our podcast now to learn more! Speaker: Carmine Liuzzi- Principa…

1
Episode 13: Updates on the IVDR 40:12

2M ago40:12

40:12

In this episode of the RAQA Café Podcast, our host engages with Warren Jameson (NAMSA’s Sr. Manager, Regulatory & Quality) and Christele Perrin-East (NAMSA’s Sr. Regulatory Consultant, IVD), to explore the extension of the EU IVDR deadline and its implications for the industry. Our experts highlight the importance of maintaining progress towards IV…

1
Why and how to build a Quality Culture?

2M ago

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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…

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Episode 179 | Michelle Lott, Principal and Founder at LeanRAQA | FDA and MDR Updates 35:16

2M ago35:16

35:16

In this episode, Michelle Lott at LeanRAQA and Duane Mancini discuss the QMSR, FDA e-start program, 513g vs. presubmission meeting, MDR update and so much more.

1
eSTAR 5.0 - What You Must Know 32:58

2M ago32:58

32:58

This is not last year's eSTAR - a LOT has changed, and there are things you need to know before you try to submit your 510k. In this episode, we'll guide you through the intricacies of the latest eSTAR 5.0 platform, crucial for those of you planning a 510k or PMA submission.We'll review the eSTAR 5.0 platform and what you need to know to use it eff…

1
Planning, Funding & Implementing a Stewardship Program - Ep 135 17:30

2M ago17:30

17:30

Discover the tools you need to plan, fund, and implement a stewardship program based on this group's experience with anticoagulation stewardship. Full text of the OPEN ACCESS manuscript is available at: https://accpjournals.onlinelibrary.wiley.com/doi/10.1002/jac5.1936

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

2M ago

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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
Bitdefender: Securing the Cloud - The Critical Role of CSPM 29:05

2M ago29:05

29:05

In this episode of Command and Control, host Aaron Banner and guests from Bitdefender delve into the increasingly crucial realm of Cloud Security Posture Management (CSPM). As more organizations migrate to the cloud, understanding and implementing effective security strategies becomes paramount. The discussion focuses on a recent Bitdefender articl…

1
Episode 178 | Kevin Saem, Commercial Director at Zapyrus | 2023 Medtech Report 42:59

2M ago42:59

42:59

In this episode, Kevin Saem at Zapyrus and Duane Mancini discuss what Zapyrus does, their 2023 Medtech report on the industry and so much more.

1
Disco Dice - The Sputnik Disko - Session 259 2:00:04

2M ago2:00:04

2:00:04

Best Discohouse and Clubgrooves by Disco Dice 2hours live on Air on Radio MDR Sputnik (Germany) DISCO DICE / Dj Team - Germany www.discodice.de Mgmt: Marco Benitz bkng: www.dnrg-mgmt.de mobil: +49 177 2504210 bookings: marco@dnrg-mgmt.de Instagram: https://www.instagram.com/discodicedj Facebook: https://www.facebook.com/discodicedj Bandcamp: https:…

1
Ontotext: Knowledge Graphs - The Key to Unlocking Hidden Insights 21:40

2M ago21:40

21:40

Ever wonder how search engines understand the difference between "apple," the fruit, and the tech company? It's all thanks to knowledge graphs! These robust and scalable databases map real-world entities and link them together based on their relationships. Imagine a giant web of information where everything is connected and easy to find. Knowledge …

1
Radiation Sterilisation Master File (ISO 11137 & 11607)

2M ago

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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
Episode 177 | Katrina Holland, Executive Director at MedTech Color | Increasing Diversity in Medtech 34:02

2M ago34:02

34:02

In this episode, Katrina Holland at MedTech Color and Duane Mancini discuss her new role at MedTech Color, closing the diversity gap in Medtech, her short, medium and long term vision of Medtech Color, and so much more.

1
European Union Deforestation Regulation (EUDR) 9:11

3M ago9:11

9:11

Our latest Assurance in Action podcast discusses the European Union Deforestation Regulation (EUDR). Our Intertek Assuris experts, Jayne Stewart and Yvonne Lenighan will discuss this new Regulation and how to comply. To learn more about EUDR, stream our podcast now. For more information on this topic, contact us at foodcontact.assuris@intertek.com.…

1
Medical Device News April 2024 Regulatory Update

3M ago

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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
Pharmacotherapy updates in pulmonary drug-resistant tuberculosis - Ep 134 15:29

3M ago15:29

15:29

Updates on the strategies, regimens and duration of the treatment of pulmonary drug-resistant tuberculosis. Full text manuscript available at: https://accpjournals.onlinelibrary.wiley.com/doi/10.1002/phar.2909

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Episode 176 | Ken Callahan, Principal at The Hargan Group; Former HHS Chief of Staff to the Deputy Secretary | United States Department of Health and Human Services (HHS) 50:56

3M ago50:56

50:56

In this episode, Ken Callahan at The Hargan Group and Duane Mancini discuss his background with HHS, what startups need to know about the department, what are the biggest policy decisions being discussed right now, how the upcoming election could affect those policies, big issues coming up in 2025 and beyond, and so much more.…

1
END-TB Trial with Dr Guglielmetti 46:27

3M ago46:27

46:27

Today we speak with Dr Guglielmetti about the END-TB trial which looks at new all oral regimens for MDR-TB. REFERENCES 1) https://endtb.org/ 2) Nyang’wa, Bern-Thomas, et al. "A 24-week, all-oral regimen for rifampin-resistant tuberculosis." New England Journal of Medicine 387.25 (2022): 2331-2343. 3) Conradie, Francesca, et al. "Treatment of highly…

1
Budget Changes to MDR, SDLT Update and Recent Tribunal Cases 46:40

3M ago46:40

46:40

In this podcast episode, we are once again joined by Patrick Cannon, Barrister, and a recognised expert on all things SDLT, for an industry update on SDLT and how the abolition of MDR in the recent budget will have an affect on the market. In this episode we discuss the recent budget changes and tax tribunal cases relating to claims for Multiple Dw…

1
ISO Management Systems – the Good, Bad and Ugly 12:58

3M ago12:58

12:58

ISO Management Systems can add value to an organisation but only if they meet the needs of the business. In this podcast we discuss ‘good’, ‘bad’ and ‘ugly’ of management systems users are experiencing and how to make improvements. Speakers Curtis Thornton, BDM Business Assurance at Intertek Cheryl Savage, MD of Management Risk Solutions Ltd Follow…

1
Beyond the Firewall: How Censornet Secures the Modern Enterprise 27:18

3M ago27:18

27:18

Gone are the days of merely safeguarding school computers! Censornet, a rising star in the tech industry, has undergone a remarkable transformation. From its roots as an internet security provider for educators, it has emerged as a trailblazing force in digital risk management. Today, Censornet offers a comprehensive suite of tools designed to conf…

1
The Rise of the Private Data Cloud and How Yellowbrick is Leading the Charge 20:43

3M ago20:43

20:43

The traditional data warehousing landscape is changing. The concept of private data cloud offers a compelling alternative to both cloud PaaS and traditional data warehousing. Imagine a secure, dedicated environment for your data, existing entirely within your organisation's control. Yellowbrick, a leader in private data cloud solutions, empowers bu…

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