show episodes
 
With the effective CAPA management system, you can resolve quality issues, improve customer satisfaction, ensure the compliance with the standards and regulatory requirements, identify and implement improvements. CAPA management software of Qualityze helps the manufacturers to integrate with the other processes that consists of the audit, nonconformance, document management, change control and also the customer responses. Read more - https://www.qualityze.com/capa-management/
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L'asturi Esteban J. Girn va nixer amb un trauma heretat: el seu pare va fer la mili a Lleida. El tamb conegut com 'el guitarrista simptic de Toundra' va haver de crixer sentint les distorsions (positives) que el seu pare li explicava sobre els catalans i sobre Catalunya. No cal dir que la seva infncia i joventut van ser una veritable auca i, al final, es va acabar installant a Madrid. Ara, en plena maduresa vital -ja ha fet 27 anys- i en qualitat de dinamitzador cultural, connecta amb 'Els e ...
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Podcast featuring the best new music by Female Indie Artists and Female-Fronted Bands in all genres hand-picked by Bree Noble. Women of Substance Radio has provided a platform for female Indie talent since 2007 and was transitioned into a Podcast in 2014. Each show features 10 - 15 songs and provides interesting tidbits about the artists.
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Artwork
 
Midwest Ghost Town is about exploring the history of abandoned towns and places in the Midwest and around the world- most importantly - we are here to tell the story of these places and the people who lived there.
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Brief description is as follows: Impromptu, random thoughts of an artist's mind of "JUAN GOMEZ", some historical references related to topics. A personal perspective of my life & events also influences. Smorgasbord of experiences what can inspire a painting or groups of them. I love progressive music especially by early "GENESIS" Peter's era... also Phil's. This experiment of literature I'm going into will be RAW, some calculated and unexpected adventures.
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Artwork
 
Can nature and technology — long viewed as opposing forces — work together to create liveable cities and improve public health? Dr. Nadina Galle is an ecological engineer on a mission to find out. Join her every Wednesday as she interviews top thought-leaders & entrepreneurs on their technologies for building greener, healthier, and smarter communities. Each episode contains powerful stories behind the innovator, delves into questions usually shied away from, and explores where the internet ...
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Released regularly, the Richard Flint Photography podcast features photography news, photo projects, website and podcast links, multimedia, videos, photography articles, upcoming exhibitions, photographic awards and more. The photography podcast is released regularly (around six episodes a year plus a number of special bonus podcasts focusing on books, photography locations and other photography-related subjects. The podcast covers all sorts of photography-related topics and issues including ...
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Stop playing that trash, coach! Listen to your new favorite podcast dedicated to Star Wars Destiny from Fantasy Flight Games. Join Mr. Chip, a washed-up former professional podcaster and wanna-be competitive player, and Jay, who has played more trash decks on Tabletop Simulator than one person should be allowed to - as they work together to make for an entertaining show you won't soon forget. Join our patreon at discardtoreroll.com and become a part of the DB family!
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Demystifying study abroad and global learning for aspiring + thriving global education professionals. Through solo shows and fun interviews, we talk about all things global education and the latest news, trends, and challenges facing the international education industry. If you're ready to geek out on all things global ed, you've come to the right place. Hosted by Brooke Roberts (@thenewdorothy), a 20+ year veteran of the international education industry, 5x study abroad student, and a solop ...
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show series
 
To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Carrie Welling - Goodbye You FOLLOW ON SPOTIFY Becky Boyland - Waiting for Wisdom FOLLOW ON SPOTIFY Reghan Cutler - Swear Jar FOLLOW ON SPOTIFY Anya Cantor - Haunted Heart FOLLOW ON SPOTIFY CELIA - Breathe FOLLOW ON SPOTIF…
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In this episode of the Global Medical Device Podcast, Etienne Nichols hosts Georg Digel, a seasoned expert in Corrective and Preventive Action (CAPA) systems. Georg shares insights into setting up an effective CAPA program, discussing essential topics like identifying CAPA triggers, executing root cause analysis, and implementing corrective actions…
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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…
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: writer David Kessner - Let's See What A Woman Can Do FOLLOW ON BROADJAM The Saraphines - Tell Me Why FOLLOW ON SPOTIFY Cassidy Dickens - Church Basement FOLLOW ON SPOTIFY Katie Cloyd - I'll Carry You Home FOLLOW ON SPOTIFY…
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Madness Maddi - My Friend FOLLOW ON SPOTIFY Jo Hill - BIG BOYS CRY TOO FOLLOW ON SPOTIFY BXRRELL - Tattoo FOLLOW ON SPOTIFY Schantell Wharton - Love and Forgiveness FOLLOW ON BROADJAM Tender Claws - I'm a Leech FOLLOW ON S…
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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…
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Sadie Fine - Meat FOLLOW ON SPOTIFY Madison Taylor - Golden Image FOLLOW ON SPOTIFY Lara Taska - Silk and Lead FOLLOW ON SPOTIFY Catlea - Crumbling FOLLOW ON SPOTIFY Katie Ainge - Ashes FOLLOW ON SPOTIFY Carrie Sams - Song…
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Emily Shirley - You Came In FOLLOW ON SPOTIFY Leanne Wilkins & the Weathered - Free Spirit FOLLOW ON SPOTIFY writer James Shepard - Keep Her Heart FOLLOW ON SPOTIFY Meredith Gleason - Thursday FOLLOW ON SPOTIFY Jola Recchi…
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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…
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Kaylyn Sahs - Wine About It FOLLOW ON SPOTIFY Lina Cooper - Don't Let Me Fall FOLLOW ON SPOTIFY Marlee Spear - The Line FOLLOW ON SPOTIFY Abbie Thomas - If I Die FOLLOW ON SPOTIFY Alice Luke x LAiTH - Hurricane FOLLOW ON S…
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Alexandra Browne - Carry Me FOLLOW ON SPOTIFY Tanisha Deka - not enough FOLLOW ON SPOTIFY South for Winter - Wintersleep (Southern Lights) FOLLOW ON SPOTIFY Noa Hadad - busy FOLLOW ON SPOTIFY Emily Volt - Hate at First Sig…
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In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Simon Mason, President of NEST (National Evaluation System for Health Technology), to explore how real-world evidence (RWE) is shaping the future of medical device regulation. Simon breaks down NEST's critical role in catalyzing the use of RWE to stre…
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Gail T as Charged - Wings FOLLOW ON SPOTIFY Raultrasound feat. Queen Chameleon - Find That Light FOLLOW ON SPOTIFY Kimberlye Gold - Move On FOLLOW ON YOUTUBE Lisa Imondi - Have You Ever (Gina's Song) FOLLOW ON SPOTIFY Cons…
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In this episode of the Global Medical Device Podcast, host Etienne Nichols continues his conversation with regulatory expert Mike Drues in part two of their series on home use medical devices. The discussion centers on critical topics such as labeling, usability challenges, and the future of medical devices in home settings. They explore how these …
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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…
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Mzee - Dreamin' Klare KuOlga - Hope FOLLOW ON SOUNDCLOUD Jen Hawley - Just Last Fall FOLLOW ON SPOTIFY Alisha Liston - Dearest Sunshine (Lux's Version) FOLLOW ON SPOTIFY Cassidy Ladden (writer Marvin Conan) - Ode To Ali FO…
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Joka Beatz - Real Talk ft Lisa Drip FOLLOW ON BROADJAM Becky Boyland - It's Your Story Now FOLLOW ON SPOTIFY Alicia Mathewson - 888 (Everything is Magic) FOLLOW ON SPOTIFY Jenny Van Alstyne - Meant for More FOLLOW ON SPOTI…
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In this episode, Etienne Nichols hosts regulatory expert Mike Drues to discuss the evolving landscape of home use medical devices. The conversation covers critical topics such as regulatory definitions, safety challenges, and compliance hurdles for devices intended for use outside traditional clinical settings. They explore how home use devices, su…
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Tanisha Menefee - I'm Going to Make It FOLLOW ON SPOTIFY Cassie Lokker - New Song FOLLOW ON SPOTIFY Carrie Sams - God is Still God FOLLOW ON SPOTIFY Becky Boyland - Surrender FOLLOW ON SPOTIFY Jaynie Hansen - Worthy FOLLOW…
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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…
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Jill Sissel - Oil FOLLOW ON SPOTIFY Jackie Morris - Money To Burn FOLLOW ON SPOTIFY Ed & Carol Nicodemi - Let a Flower Grow FOLLOW ON SPOTIFY Klare KuOlga - Breathe FOLLOW ON SPOTIFY Jeanie Cunningham - Nature's Cry FOLLOW…
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Anitra Carr - Dignity FOLLOW ON SPOTIFY Sparrows Landing Global - Heart Of The East FOLLOW ON SPOTIFY Carlene Thissen - Couple Of Strays FOLLOW ON SPOTIFY Ed & Carol Nicodemi - Save a Child FOLLOW ON SPOTIFY Bree Noble - M…
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Waking Stone - Homeland of the Free FOLLOW ON SPOTIFY SoulMama Jane - State Of Decay Jill Sissel - Dear America FOLLOW ON SOUNDCLOUD Evie Ziegler - Contagious FOLLOW ON SPOTIFY Hatori - The Butcher FOLLOW ON SPOTIFY Lourde…
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In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator. Vincent brings 30 years of life sciences and regulatory expertise, offering a unique perspective on navigating FDA inspections, building robust quality …
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Wheel House - Cookie Jar FOLLOW ON SPOTIFY Christian Schormann - Dereliction FOLLOW ON SPOTIFY Surya Devi - Win This War FOLLOW ON SPOTIFY Jackie Morris - House of Cards FOLLOW ON SPOTIFY RiverHouse Music - Paper Thrones F…
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue speaking on the topic of predetermined change control plans. Potential scenarios for their use are discussed, examples are provided, and role of PCCPs for manufacturing processes are explored. If you haven’t yet listened to Part 1…
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the FDA’s recent guidance documents regarding predetermined change control plans (PCCP). The first guidance addresses PCCPs for artificial intelligence (AI) and/or machine learning (ML) based devices (click here to hear an earlier …
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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 …
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Gail T as Charged - Freak Flag Fly FOLLOW ON SPOTIFY CW Anderson - Half & Half FOLLOW ON BROADJAM Judy Nazemetz - Behind That Locked Door FOLLOW ON SPOTIFY Christian Schormann - Tolerance FOLLOW ON SPOTIFY Cathy Hutch - A …
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Catherine M Thompson - I Want Out FOLLOW ON SPOTIFY Stephanie Rabus - Halo (Outside Looking In) FOLLOW ON SPOTIFY Randie's Werewolves Of Summer - Daddy's Pride FOLLOW ON SPOTIFY Jeanie Cunningham - Lady Ayn Chorus of Coura…
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In this episode, Etienne Nichols talks with Leo Eisner, renowned as the "IEC 60601 Guy" and founder of Eisner Safety Consultants, about the importance of selecting the right standards in medical device development. Leo shares his journey into the world of medical device standards, offering a detailed look into the role that standards play in ensuri…
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Bree Noble - Stand Up Judy Nazemetz - The F Word FOLLOW ON SPOTIFY PJ Brunson - Free to Choose FOLLOW ON SPOTIFY Anthea Jewels - I'm a Blues Woman Michelle Perron feat. Jenn Foss - 7 Trumpets FOLLOW ON SOUNDCLOUD Redneck P…
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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…
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Seiren - Hell Hath No Fury FOLLOW ON APPLE MUSIC Cassandra Vohs-Demann - We Are FOLLOW ON SPOTIFY Becky Boyland - I Don't Have Time FOLLOW ON SPOTIFY Evan Pace - Don't Hold Me Back FOLLOW ON BROADJAM Stephanie Phillips - T…
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Louise Wisechild - I'm Not the Enemy FOLLOW ON SPOTIFY Renee Allsbrook - Sweet America FOLLOW ON SPOTIFY Voices Three - The High Ground Jeannie Novak - Frontier FOLLOW ON SPOTIFY Sista Jean & CB + Pepper MaShay - Shadow Pe…
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In this episode, Etienne Nichols interviews Perry Parendo, an expert in Design of Experiments (DOE), about the practical application of DOE in medical device development. They discuss how DOE can be used to better understand systems, reduce risk, and solve complex problems, especially in R&D and manufacturing processes. Perry shares insights from h…
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Jen Hawley - Wage War FOLLOW ON SPOTIFY Yvette Medina - We'll Always Remember 9_11 FOLLOW ON SPOTIFY Jackie Morris - Devil in the Heartland FOLLOW ON SPOTIFY Cece Otto - I Didn't Raise My Boy to Be a Soldier FOLLOW ON SPOT…
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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…
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Catherine M Thompson - Put Down The Guns FOLLOW ON SPOTIFY Stephanie Phillips - The Last Word FOLLOW ON SPOTIFY Jackie Morris - Crazy Eddie Got a Gun FOLLOW ON YOUTUBE Liz Miller - AR-15 FOLLOW ON YOUTUBE Suki Rae - Shame,…
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To get live links to the music we play and resources we offer, visit www.WOSPodcast.com This show includes the following songs: Anna-Vee's Blue Smoke - Lockdown Blues FOLLOW ON SPOTIFY Cashavelly - Rewrite FOLLOW ON SPOTIFY LittleFox - Ghost In This House FOLLOW ON SPOTIFY Carlene Thissen - Steady As She Goes FOLLOW ON SPOTIFY Ann Kim - Lowest Low …
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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…
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In this episode of the Global Medical Device Podcast, host Etienne Nichols speaks with Dr. Asha Parekh, CEO and co-founder of Frontline Medical Technologies, about her path from a biomedical engineer to an "accidental entrepreneur." Dr. Parekh shares how her desire to create impactful medical devices led to the development of the COBRA-OS, a life-s…
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