Medical Device Regulation public
[search 0]
More

Download the App!

show episodes
 
RCA Radio covers the latest news and challenges in regulatory, compliance, and quality assurance facing the medical device, pharmaceutical, and biologic industries. Each episode, join Regulatory Compliance Associates® Inc. (RCA) and industry thought leaders as we navigate the issues that matter to you most.
 
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues is a legal podcast hosted by Arnall Golden Gregory LLP. In this podcast series, different members of our Food & Drug practice and colleagues in other related life science teams will discuss issues and challenges they have encountered when assisting clients on business and legal matters.
 
Loading …
show series
 
In this second episode on System and Procedure Pack, we answer more questions about this way to place devices on the market. Erik got some experience with the authorities that he will share with us and I have created some cases that I will propose to Erik and see how he would manage them. Erik will also talk more about IVDR as this is a topic of hi…
 
We received the First Expert Panel Opinion and by reading it you can say a lot. So to help us have a good interpretation of it, I have asked Bassil Akra to be my guest on this podcast episode. We will remind you what is the Expert Panel, then we’ll discuss more deeply the Opinion received and finally, we will provide you some advice on how to avoid…
 
In this episode of the podcast, we will provide an update on the Medical Device industry for the period June July 2021. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to cre…
 
In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and Genevieve M. Razick, an attorney in our Healthcare and Food & Drug practices, along with Leah D. Braukman, an attorney in our Corporate & Finance practice, discuss the specifics of the small business user fee waiver, who qualifies, and how to apply from an FDA and corporate perspect…
 
State-of-the Art is an important topic but not well understood. It’s why I have invited Hakan Inan from Requalite to help us get a better understanding of this concept that you should use on your Clinical Evaluation or Performance Evaluation. We will talk not only about MDR but also about IVDR as this concept is required for both. Don’t hesitate to…
 
In this episode of the podcast, I wanted an expert to answer the question about IP related to Medical Devices. A lot of people are willing to understand how intellectual property works when for example: We have a Private Labeling Business When we buy a product already designed by another company but place it on the market under your name? When we w…
 
Clinical Investigation is one of the toughest process within the EU MDR 2017/745. If you have to perform one for your Medical Devices then it can be a long and expensive process. In this episode, Helene Quie from Qmed Consulting, will help us understand how to perform it in a good way. This episode will answer some of the questions you have about C…
 
We talked a lot about the regulatory requirements for your Medical Devices. Now let’s talk about something more technical which is the Biological Evaluation following ISO 10993-1 or also called Biocompatibility. This is something that is key for the Medical Device Manufacturers but it is also not well understood. So Ana Luiza Cassin Duz, a Clinical…
 
This is the last episode of Season 1. Join us in the Fall for Season 2, and in the meantime, please take our brief survey! http://bit.ly/theaihealthpodcast Dr. Daphne Koller is CEO and Founder of insitro, a machine-learning enabled drug discovery company. She has been a Stanford CS Professor, co-founder of Coursera and Engageli, one of TIME Magazin…
 
Ok, this month the EU MDR is LIVE so we will talk about that. The date of application for EU MDR 2017/745 was May 26th, 2021 and there is a lot of information that I will share with you. We will talk about EU MDD bye bye party Webinars EU MDR impact on other countries Swixit Turkxit IVDR 2017/746 Notified Body Situation MDCG guidance IMDRF guidance…
 
Bakul Patel is the director of the FDA's Digital Health Center of Excellence. In this interview, he shares his perspective on approving AI systems. He discusses how the FDA is evolving to keep up with the medical AI market, and he addresses key ethical concerns such as equity and access. Pranav and Adriel first give an overview on the FDA's premark…
 
Last year we had reviewed the result of the EU MDR Survey made by Climedo and this year we check the difference. Do you think that there will be a big change? Climedo has decided to ask questions related to the EU MDR but also to the context due to Coronavirus. So we are now looking at the result and you’ll see that there are some changes. But stil…
 
Harlan Krumholz is a cardiologist and scientist at Yale University and Yale New Haven Hospital. He is the Harold H. Hines, Jr. Professor of Medicine and is the founder and Director of the Yale Center for Outcomes Research and Evaluation (CORE), one of the nation’s most prominent groups working to improve health and health care. In this interview, h…
 
MDR is coming In 1 week and before that, I asked Erik Vollebregt from Axon Lawyers about some questions that I receive. We will talk about: – EU MDR IVDR postponement or not? – Economic Operators date of application – PRRC do we need it from day 1 – Exclusion from EU MDR – OEM OBL rules from May 26th, 2021 And Erik announces the content of its book…
 
Mike Coyle is the CEO of iRhythm, and Mark Day is the Executive Vice President of Research & Development of iRhythm, a digital healthcare company redefining the way cardiac arrhythmias are clinically diagnosed by combining wearable biosensing technology with cloud-based data analytics and machine learning capabilities. Together, they speak with us …
 
In this episode of the Podcast, we will explain to you what is the Emergency Use Authorization (EUA) that can be started in the US. And to help us, I have invited Michelle Lott from Lean RAQA. This process was used a lot recently for Coronavirus products but you will see with Michelle that this process was changed so many times that it can create s…
 
Dr. Eric Topol is a cardiologist, a professor, a best-selling author and the founder and director of the Scripps Research Translational Institute. In this wide-ranging conversation, he explains how medical AI can harness new data sources, draw novel connections and restore the human connection between doctor and patient. He also discusses key chall…
 
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the worl…
 
Wahoo!! We are close to it now. The EU MDR 2017/745 Date of Application is arriving quickly. So for this episode, I wanted to check with you if you are ready. I will provide you first with the Scope for this date. Which products have to be ready by May 26th, 2021. Then we will talk about the documents that should be available. This list may not be …
 
Connor Landgraf is the CEO and co-founder of Eko, a cardiopulmonary digital health company. He speaks with us about AI for auscultation, the unique challenges of developing hardware as well as software, and the roller-coaster ride of running a start-up. Pranav and Adriel first give an overview on the history of the stethoscope. The interview with C…
 
Subscribe Merger and Acquisition sound like a financial topic but you’ll see that all the ways lead to Quality and Regulatory Affairs. In this episode, Erik Vollebregt, Partner at Axon Lawyers will be helping us to understand why you should have some Quality and Regulatory affairs knowledge when you are running a Merger and Acquisition with a Medic…
 
Dr. Riitta-Liisa Valijärvi, associate professor in Finnish and minority languages, and PhD candidates, Charlotte Doesberg, and Amanda DiGioia, join “Talking Europe” to discuss their new edited volume, which brings together the fascinating pairing of rock music and research.The three SSEES researchers are the co-editors of ‘Multilingual Metal Music:…
 
Dr. Emma Pierson is a senior researcher at Microsoft Research and an incoming assistant professor of computer science at Cornell Tech. Her work has been recognized by a Rhodes Scholarship and Forbes 30 Under 30 in Science, and she has written for publications like The New York Times, FiveThirtyEight, The Atlantic, The Washington Post, and Wired. Sh…
 
Joelle Pineau is co-Managing Director of Facebook AI Research (FAIR), supporting labs across North America and Europe. She is also a faculty member at Mila and an Associate Professor and William Dawson Scholar at the School of Computer Science at McGill University, where she co-directs the Reasoning and Learning Lab. She speaks with us about FAIR's…
 
Subscribe We talked a lot about the EU MDR and the difficulty for some manufacturers to transition to this new legislation. But today we will explain why IVDR manufacturers will struggle more. I will explain to you the change in terms of product classification within the IVDR 2017/746. Because of this, a lot of manufacturers that didn’t need a Noti…
 
Dr. Kiersten Stead is a Managing Partner at DCVC Bio, a venture capital fund supporting companies using deep tech within life science industries. She talks with us about opportunities within biomedical AI, especially around making clinical trials more efficient. Pranav and Adriel first give an overview on digital twin technology for the interview, …
 
Subscribe This podcast episode is following a presentation I have made during the Greenlight Guru Summit on EU MDR and IVDR. I have explained how to create a label that fulfills the requirements of the EU MDR. I have placed on the show notes the link to it. After the session, I have received a lot of questions and I didn’t have the time to answer a…
 
Dr. Charles Cadieu is the co-founder and CEO of Caption Health. Previously, he was an expert in deep learning at MIT and Berkeley and was a founding member of IQ Engines, acquired by Yahoo!. In this interview, he explains how Caption Health is using AI to make it easier for clinicians to capture high-quality ultrasound images. He also discusses bro…
 
Subscribe Let’s discuss System and Procedure Pack. We usually talk about medical devices like as an object that is used in the healthcare industry. But when you have to combine multiple objects, how can you then regulate that. Is there one classification for all or should you classify and register each of them. And what if all these objects are alr…
 
Subscribe With the EU MDR 2017/745 and IVDR 2017/746 the role of Economic Operators is becoming clearer. In the case you are located outside of Europe and you need to import your Medical Devices in the EU, you need to have an Importer. In this episode we will talk of the importer role and what they need to check before your product is placed on the…
 
Dr. Adewole "Ade" Adamson is a board-certified dermatologist and assistant professor in the Department of Internal Medicine at Dell Medical School at the University of Texas at Austin. He speaks with us about AI applications in dermatology and addresses challenges around racial bias and overdiagnosis. Pranav and Adriel first talk about the potentia…
 
Subscribe This month we will review what happened within the Medical Device Industry and there was some updates. Here is the agenda: EUDAMED Covid19 Language for EU MDR 2017/745 MHRA virtual manufacturer update Australia Nanoparticle consultation Singapore Medical device grouping tool Saudi Arabia covid 19 update Easy Medical Expert Green Belt Trai…
 
In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and co-chair of AGG’s Data Privacy practice, Kevin L. Coy, discuss U.S. and international privacy and data security law issues life sciences companies may encounter such as privacy policies, the patchwork of federal and state privacy and data security laws in the U.S., international dat…
 
Dr. Vijay Pande is a general partner at Andreessen Horowitz and an Adjunct Professor of Bioengineering at Stanford University. As the founding investor of a16z’s Bio Fund, he leads the firm’s investments at the cross section of biology and computer science. He speaks with us about drug discovery and other major opportunities for entrepreneurs in th…
 
In this episode of RCA Radio, host Brandon Miller and Steve Lynn, who is Regulatory Compliance Associates (RCA) Executive VP of Pharmaceuticals, provide an outlook into the most important things happening in 2021 to the Pharmaceutical industry such as; timeliness in regards to vaccines and EUAs, virtual inspections, cellular and gene therapy, facil…
 
Subscribe I am really honored to have within this episode of the Podcast Jon Speer. I was already following him before I started Easy Medical Device and now I had the opportunity to interview him. We discussed Medical Device Design, and I wanted his opinion on the best design methodology to use and which trap to not fall in. We discussed particular…
 
Andrew Ng is Founder of DeepLearning.AI, General Partner at AI Fund, Chairman and Co-Founder of Coursera, and an Adjunct Professor at Stanford University. A pioneer in both machine learning and online education, Dr. Ng now focuses primarily on his entrepreneurial ventures, looking for the best ways to accelerate responsible AI practices in the larg…
 
Subscribe If you find it difficult to get a job in QA RA for Medical Devices, then listen to this episode where Monir El Azzouzi and Karandeep Badwal are giving you some tips on how to integrate this world. They will provide you some tools to use, some podcasts to listen to, some groups to follow. And for sure this will move you few steps forward. …
 
In this episode of RCA Radio, host Brandon Miller and Seyed Khorashahi, who is Regulatory Compliance Associates (RCA) Executive VP of Medical Device and CTO, provide an outlook into the most important things happening in 2021 to the medical device industry such as; Brexit, the European Medical Device Regulations (EU MDR), In Vitro Diagnostic Regula…
 
Subscribe Michelle Lott and I are discussing our Experience in the Quality and Regulatory affairs area. We will help you define what is compliance and how we think it should be applied. Michelle had also some good and bad experiences that she is sharing with us. Who is Michelle Lott? Michelle Lott is the founder and principal of leanRAQA, which has…
 
Our guests today are Dr. Alastair Denniston and Dr. Xiao Liu. Together they discuss their work on SPIRIT-AI and CONSORT-AI, two pioneering sets of guidelines that help researchers conduct and report AI clinical trials in a safe, transparent manner. Dr. Alastair Denniston is a consultant ophthalmologist, an honorary professor at University Hospitals…
 
Subscribe In this monthly episode of the podcast, we do a regulatory intelligence review of what happened monthly. The agenda for this month is: Countdown until EU MDR by Michelle Lott (LeanRAQA) Remote Audit authorized for EU MDR SURVEY Result US update on Recognised Consensus Standards Canada guidance on Vigilance Reporting Training available Not…
 
In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and team member, Genevieve M. Razick, give an overview of FDA’s Office of Prescription Drug Promotion’s (OPDP) enforcement of unlawful advertising in 2020.By Arnall Golden Gregory LLP
 
Our guest today is Zavain Dar, a partner at Lux Capital and a founding investor in Anagenex. He speaks about his investments in cutting-edge medical tech companies, especially in the drug discovery space. He also describes common pitfalls faced by medical start-ups and gives advice to aspiring entrepreneurs. Pranav and Adriel first discuss Pfizer-B…
 
Subscribe PMS is one of the processes that is changing due to EU MDR and I wanted to come back to it with Ivan Perez Chamorro from MedBoard. MedBoard is a solution that helps you with your Regulatory Intelligence. And Ivan is trying to make the life of the companies easier by providing some tools. In this episode, Ivan will first explain to us what…
 
Our guest today is Dr. Lily Peng, a product manager at Google Health. Named to Fortune's 2020 "40 Under 40 - Healthcare" list, she describes her work on automatic disease screening, exploring the challenges of design and deployment. She also discusses her own career path and the role of Big Tech in healthcare. Pranav and Adriel first discuss the ch…
 
Subscribe Artificial Intelligence. This is the topic of today’s podcast episode. We will help you understand how to place AI Software as a Medical Device in the EU Market with the new EU MDR 2017/745. For that, I have with me Leon Doorn from Aidence who is explaining to us its journey to get EU MDR 2017/745 certified. You will first understand what…
 
Our guest today is Ian Shakil, Founder, Director, and Chief Strategy Officer of Augmedix. He explains how Augmedix is changing how electronic health records are generated, saving doctors time and improving patient experience. He also tells the story of how he founded Augmedix, and he discusses how his company differentiates itself in a competitive …
 
Subscribe Registration of products in different countries is always a Challenge. And for Israel, this is the same. I have invited Liat Nadel from L.S. Marketing & Registration to help us understand the situation and how to succeed in the registration process. We will talk also about the possibility to use registrations already done in Europe and th…
 
Our guest today is LLana James, Faculty of Medicine and PhD candidate at the University of Toronto and the AI, Medicine & Data Justice Post Doctoral Fellow at Queen’s University. She explains how racism has shaped Western medical practice, and she discusses the insidious ways in which old biases resurface in modern medical AI. Pranav and Adriel fir…
 
Loading …

Quick Reference Guide

Copyright 2021 | Sitemap | Privacy Policy | Terms of Service
Google login Twitter login Classic login