show episodes
 
A podcast about cybersecurity and the people that keep the internet safe.The podcast is built as a series of segments: we will be looking back at the last couple of weeks in cybersecurity news, talking to different people in the industry about their thoughts and experiences, we're going to break apart some of the TTPs being used by adversaries, and we will even cover a little bit of hacker history.
 
The TBPod is a podcast for clinicians and policymakers caring for patients with tuberculosis. The podcasts present discussions with expert clinicians, researchers, policymakers and advocates about their work in the field of tuberculosis. Tuberculosis remains one of the leading causes of death worldwide, and is an important contributor to morbidity among migrants arriving in Australia and New Zealand. There are around 1300 reported cases of TB in Australia each year, and a further 300 in New ...
 
Welcome to the Combinate Podcast, a show that brings you closer to what makes MedTech and BioTech incredible, the people behind the scenes. I’ve worked on product development teams in the Medical Device and Pharmaceutical industries for the last decade of my life and my aim with this podcast is to understand. Each week, I sit down with leaders to examine the roadblocks in development and access we face and bring to light concepts and tools from our industry and others that will help address ...
 
RQM+ industry-leading experts discuss regulatory and quality challenges medical device and diagnostic companies are facing. RQM+ is the leading international provider of regulatory, quality, and compliance consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs, and committed to deliv ...
 
This podcast features the latest interview in the areas of compliance, risk management and e-learning. Topics include ESG, AML, GDPR, harassment, FCPA, anti-bribery and more. Founded in 2004, VinciWorks is a leading provider of online compliance training and risk management software. With over 200,000 users across 70 countries, VinciWorks has established itself as the definitive authority in online compliance. VinciWorks offers a range of compliance and regulatory training courses on topics ...
 
A weekly show where we discuss large ideas on life, sports, hip hop, and anything else we want to discuss. We sometimes have interesting guests that come onto the show and tell us about themselves and give their perspectives. The title itself is satire about myself, if you listen then you'll understand it. Stay blessed!
 
From ransomware attacks to supply chain compromises, eSentire’s Cyber Talks podcast will delve into the world of the latest cyber threats that are impacting businesses globally. Join our team of security experts as we speak with C-level executives and security practitioners about the cyber risks affecting their business and how they’re addressing these challenges. eSentire is The Authority in Managed Detection and Response, protecting the critical data and applications of 1500+ organizations ...
 
New Hi, I’m Margaret and this is Pedagogy What? The Confessions of a First-Year Teacher. I just started my first year of teaching and this podcast is going to be about the ups, the downs, and the crazy that happens as I progress through this year. This podcast is for new teachers, veteran teachers, teachers to be, and anyone else interested in this journey that is the next year of my life. Art by Apple Vectors by Vecteezy
 
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show series
 
MDR has been puzzling me for a few years now, and it's getting worse, not better. In this webinar hosted by Greenlight Guru, we look at the data gathered from recent MDCG guidance documents, industry and notified body surveys, and personal interviews with stakeholders (including notified bodies) who shared their first-hand experiences with implemen…
 
On this episode, I was joined by Christiana Hoffman, Executive Consultant & Business Development Manager at anteris medical GmbH. Christiana walks through: - Article 117 requirements for Combination Products in EU - Notified Body Opinions, Timelines, and Interactions\ -Reporting for Combination and when does Eudamed Apply Christiana is a medical de…
 
In this episode, Nick Henderson and Naomi Grossman examine a compliance case that rocked the world of Credit Suisse, the venerated global investment bank and a crown jewel of Switzerland. It seems that Credit Suisse has been lurching from one scandal to the next, much of it due to their lack of serious anti-money laundering efforts. But this case i…
 
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:…
 
Liam Messin of The Lancet Global Health talks to Professor Simon Wigley and Dr Luke Allen about their research investigating the implementation of global non-communicable disease policy worldwide. Read the full article: Non-communicable disease policy implementation from 2014 to 2021: a repeated cross-sectional analysis of global policy data for 19…
 
In this episode, we sit down with Matt Bromiley to talk about some of the latest intel coming out of the LimaCharlie community Slack channel: A new Microsoft Word Vulnerability: CVE-2023-21716. The Emotet botnet is back spamming again. A previously undisclosed toolset used by Sharp Panda, a long-running Chinese cyber-espionage operation targeting S…
 
On this episode, I was joined by Joanna Gallant of JGTA. Joanna walks through: Training programs at companies that had consent decrees The difference between good training and bad GMP training Competence in knowledge work Human Error Joanna Gallant is an experienced, solutions-driven Quality and training professional who has spent more than 30 year…
 
Vigilance Reporting is a process you should have but don’t want to use. In fact not having any vigilance reporting is a sign that your product is doing well. But having one means that maybe you need to improve your device. So in this episode, we will explain to you what is Vigilance Reporting and how you should build it. We will explain EU reportin…
 
Becky Holmes knows how to throw a romance scammer off script—simply bring up cannibalism. In January, Holmes shared on Twitter that an account with the name "Thomas Smith" had started up a random chat with her that sounded an awful lot like the beginnins stages of a romance scam. But rather than instantly ignoring and blocking the advances—as Holme…
 
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:…
 
On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: - FDA Drug Shortages Report - Drug Shortages and Drug Pricing - How he approaches Mastering new skill sets and building deep understanding in new areas Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality a…
 
In this episode, we sit down with Matt Bromiley to talk about some of the latest intel coming out of the LimaCharlie community Slack channel: Menlo Labs has uncovered an unknown threat actor that’s running an evasive threat campaign which is being distributed via Discord and is targeting government entities. TA569 is a prolific threat actor who has…
 
Here is your Regulatory Update for the month of March 2023. Check all the links on Medboard Platform: https://www.medboard.com/reports/easy-medical-device-regulatory-update/2023/march/ – EU MDR 2017/745 extension has been voted: https://www.raps.org/news-and-articles/news-articles/2023/2/europeanparliament-votes-to-extend-mdr-transition -UK Impact …
 
In this episode, we sit down with Matt Bromiley to talk about some of the latest intel coming out of the LimaCharlie community Slack channel. After that, an interview with Nick Gipson, Director of Cyber Operations at Pareto Cyber. The Cybersecurity Defenders Podcast: a show about cybersecurity and the people that defend the internet.…
 
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, Tautvydas from Test Labs will explain to us what is expected from Medical Device Manufacturers. What they should prepare for being compliant with the new regulation? Who is Tautvydas Karitonas? Tautvydas …
 
Under UK law, a corporation can face criminal prosecution if it fails to prevent certain actions from being undertaken by its employees or contractors. The UK government have recently announced they are pushing ahead with a game-changing new regulation to expand the ‘failure to prevent’ family of offences to fraud. In this episode, Director of Lear…
 
Government threats to end-to-end encryption—the technology that secures your messages and shared photos and videos—have been around for decades, but the most recent threats to this technology are unique in how they intersect with a broader, sometimes-global effort to control information on the Internet. Take two efforts in the European Union and th…
 
On this episode, I was joined again by one of my favorite people in risk management, Naveen Agarwal of Creative Analytics Solutions and ExceedQM. Naveen discusses: The Anatomy of a Hazard Hazard Source(HS), Initiating Mechanisms (IM) and Target-Threat Outcome (TTO) Clifton Ericcson How concepts/tools like these fit into the ISO14971 and ISO TR 2497…
 
In this episode of the Cybersecurity Defenders podcast, we recount some hacker history, and with the help of Marcus Hutchins, tell the story of the WannaCry ransomware attack. The WannaCry ransomware attack was a worldwide cyberattack in May 2017 by the WannaCry ransomware cryptoworm, which targeted computers running the Microsoft Windows operating…
 
Upload to EUDAMED is a requirement of MDR, but adoption has been slower than anticipated. Manufacturers are reluctant to invest in the time required to upload their product catalog, and the platform itself has been plagued with issues. Listen in as Richard Houlihan lifts the curtain on why industry has been reluctant to embrace EUDAMED and what the…
 
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 mainly what we will discuss on this Podcast. We will use the example of SaMD or Software as a Medical device for it and share with you the experience that we have but this is applicable to nearly all me…
 
In November 2022 HMRC released the summary of responses from their consultation on the UK’s Mandatory Disclosure Rules (MDR). The consultation clarified that: 1. The historic lookback period will go back to 25th June 2018 (and not 29th October 2014 as originally stated). 2. Reporting will be via XML only. With UK MDR expected to come into force in …
 
This is audio from RQM+ Live! #64, recorded 16 February 2023. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website. Over the past several years the expectations for testing of medical devices per the ISO 10993 standards has significantly changed and continues…
 
Nina Putnis of The Lancet Global Health speaks to Professor Pamela Jeyaraj and Mr Stephen Knight about their research understanding the link between malnutrition and outcomes after surgery for bowel cancer across 75 countries. Read the full article: Impact of malnutrition on early outcomes after cancer surgery…
 
On this episode, I was joined by Dan Formosa, legendary designer and founder of ThinkActHuman. On this episode, Dan walks through:- Eliminating the need for instruction through good design- Drug/Device Combination Product Usability- Collaborating with OXO on a Pre-Filled Syringe- Creating the worlds first toothbrush designed for children- Usability…
 
This week on the Simply Cyber Report: Scores of Redis servers infested by sophisticated custom-built malware. Oktapus hackers are back and targeting tech and gaming companies. Russian hackers using new Graphiron information stealer in Ukraine. New QakNote attacks push QBot malware via Microsoft OneNote files. Fresh, buggy Clop ransomware variant ta…
 
In this podcast episode, Laura and Paul will share with us the big mistakes done by some Medical Device manufacturers when they are considering Biological Evaluation for their products. You may need to take some notes as Laura and Paul are really knowledgeable on this process as they are onboarding some of their customers at ICARE Group and they wi…
 
In November of last year, the AI research and development lab OpenAI revealed its latest, most advanced language project: A tool called ChatGPT. ChatGPT is so much more than "just" a chatbot. As users have shown with repeated testing and prodding, ChatGPT seems to "understand" things. It can give you recipes that account for whatever dietary restri…
 
On this episode, I was joined by Etienne Nichols, who is a Medical Device Guru and Host of the Global Medical Device Podcast. Etienne Discusses: -Translating lessons from the Steel Industry into MedTech -His experience on combination products - What is the most important quality system element? Etienne Nichols is a Medical Device Guru and Mechanica…
 
In this episode of the Cybersecurity Defenders Podcast, Matt Bromiley opens up the Adversary Toolbox to tell us all about BITS jobs. We also sit down with Tyler Shields: a cybersecurity veteran, entrepreneur, and angel investor. In our conversation, we talk about the economic conditions driving the tech sector layoffs we are seeing, what zombie com…
 
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.europa.eu/medical-devices-sector/new-regulations_en – Proposal for extension consultation: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13684-Medical-devices-transition-period…
 
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:…
 
On this episode, I was joined by Paul Jansen, who's a drug/device consultant, advisor, and board member in the combination products space. Paul discusses: - His experience leading combination product focused organizations at Eli Lilly & Sanofi - The first autoinjectors and the history surrounding ISO 11608 - Managing a product line, owning P&L and …
 
Microsoft has started blocking the execution of XLL add-ins downloaded from the Internet. The hacking group DragonSpark is leveraging Golang source code interpretation to evade detection. Threat actors are turning to Sliver to replace more popular frameworks Cobalt Strike and Metasploit. Over 4,500 WordPress sites have been hacked and Emote malware…
 
Today we speak to Professor Jan-Willem Alffenaar from Westmead Hospital and the University of Sydney about Therapeutic Drug Monitoring in Tuberculosis. Professor Alffenaar reviews the PK/PD issues with common TB medications, the strengths and weaknesses of TDM and how best to utilise TDM in the treatment of TB patients. REFERENCES 1) personalised d…
 
What happens when two regulatory consultants sit down for a chat about MDR?A lot of distressed head shaking, for sure and an equal measure of what-were-they-thinking eye rolls, but we also dug into the meat of the proposed extension and what it might mean for industry.Monir El Azzouzi and I chatted last month about MDR, and while we didn't solve al…
 
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 the US you will see that this is really completely different. For that, I have invited Robert Packard to help us understand the rules behind it and also talk about an IT application that can help you …
 
In 2020, a photo of a woman sitting on a toilet—her shorts pulled half-way down her thighs—was shared on Facebook, and it was shared by someone whose job it was to look at that photo and, by labeling the objects in it, help train an artificial intelligence system for a vacuum. Bizarre? Yes. Unique? No. In December, MIT Technology Review investigate…
 
This is audio from RQM+ Live! #63, recorded 26 January 2023. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website. The MedTech industry is one of the most heavily regulated industries in the world. The regulatory landscape is changing rapidly and regulations …
 
In a rapidly changing economy, companies are ever more reliant on a well-functioning supply chain to get things done. From outsourcing payroll to launching a new product, supply chain management has never been more crucial. Examining the risks posed by new suppliers is equally vital. A worrying incident can have a knock-on effect on your business, …
 
In this episode of the Cybersecurity Defenders podcast, we recount some hacker history and tell the story of Amit Serper, a hacker and reverse engineer, who was instrumental in stopping the most devastating cyber attack in history: NotPetya. On 27 June 2017, a major global cyberattack began (Ukrainian companies were among the first to state they we…
 
On this episode, Michelle Lott discusses the EU MDR Extension that was formalized by the European Commission and what it means for industry. If you'd like to hear more about Michelle checkout episode 031 "The 5 stages of Regulatory Grief" and checkout Michelle's Blog @ LeanRAQA.com) and Michelle's Podcast RAQA Today.Michelle Lott is the founder and…
 
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 need to define the risk of using a particular technology against another. I mean that risk-benefit evaluation is mainly what helps us to decide that our product is safe and performant. So on this epis…
 
Our PMCF trio is back with another #MedTechVoices clip. Mini series: ⚙️ 𝐏𝐫𝐨𝐚𝐜𝐭𝐢𝐯𝐞 𝐏𝐌𝐂𝐅 𝐃𝐚𝐭𝐚 𝐰𝐢𝐭𝐡 𝐄𝐜𝐨𝐧𝐨𝐦𝐲 𝐚𝐧𝐝 𝐄𝐱𝐩𝐞𝐝𝐢𝐞𝐧𝐜𝐲 In this episode, Jaishankar Kutty, Ph.D., Niki Caporali Spaniel, RAC and Torrie DeGennaro explore the path from CER to PMCF plan (regulatory perspective). We hope you enjoy! The PMCF mini series at a glance: 🔑 1. Focused on notifi…
 
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:…
 
Liam Messin of The Lancet Global Health talks to Associate Prof Refiloe Masekela and Prof Luis Garcia-Marcos about their research investigating the control and management of asthma worldwide. Read the full article: Asthma management and control in children, adolescents, and adults in 25 countries: a Global Asthma Network Phase I cross-sectional stu…
 
Our PMCF trio is back with another #MedTechVoices clip! Mini series: ⚙️ 𝐏𝐫𝐨𝐚𝐜𝐭𝐢𝐯𝐞 𝐏𝐌𝐂𝐅 𝐃𝐚𝐭𝐚 𝐰𝐢𝐭𝐡 𝐄𝐜𝐨𝐧𝐨𝐦𝐲 𝐚𝐧𝐝 𝐄𝐱𝐩𝐞𝐝𝐢𝐞𝐧𝐜𝐲 In this episode, Jaishankar Kutty, Ph.D., Niki Caporali Spaniel, RAC and Torrie DeGennaro dive into sufficient quality and quantity of clinical evidence. We hope you enjoy! The PMCF mini series at a glance: 🔑 1. Focused on notifie…
 
In this episode of the Cybersecurity Defenders Podcast, Matt Bromiley opens up the Adversary Toolbox to tell us all about RDP. We also sit down with Michael Laudenslager, VP of Cybersecurity at Churchill Mortgage and talk about security in the cloud. The Cybersecurity Defenders Podcast: a show about cybersecurity and the people that defend the inte…
 
On this episode I was joined by David Rutledge, author of Mythical Medical and CEO of Global Strategic Solutions. David Discusses: · His book Mythical Medical · Benefit (As part of Benefit/Risk) · PRRC Role and EU MDR David R Rutledge, Pharm.D., FCCP, FAHA is a results-oriented consultant for clinical evaluation and investigation, clinical risk man…
 
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