show episodes
 
A podcast capturing the stories of scientific brilliance. For a long time, science podcasts have been about DrySci (“Dry science”). It relates topics at too high a level or too generalistic. We aim to change that by bringing the stories of the people, their motivations and specifically the struggles and glories of stories past that will seek to reinvigorate, rejuvenate and respect the minds before the results. This podcast is an effort to soothe that incurable itch in your brain. We ask ques ...
 
N
Next Generation Design

1
Next Generation Design

Siemens Digital Industries Software

Unsubscribe
Unsubscribe
Monthly
 
As product engineering tools continue to morph and expand at speeds human expertise may not be able to endure, Revolutionary design technologies that span beyond industry borders, will prove their necessity for companies looking to take over their markets in the future. What will the future of design technologies and machinery look like? What will your digitalization story be? Where engineering meets tomorrow. See acast.com/privacy for privacy and opt-out information.
 
Loading …
show series
 
What in the world is a Bioelectronic Medicine? As promised, link to schema below 👇🏻👇🏻 Link to Schema on Bioelectronics Medicines Framework: here SKRAPS will remain free, but the production is not. If you would like to help us, please visit here. Episode Description: “Tis but thy name that is my enemy; Thou art thyself, though not a Montague. What’s…
 
As promised last month, here is part 2 of the story of sound design for the PsychedeRx series - a documentary exploring the therapeutic potential of psychedelics. This series in its entirety can be accessed here using this LINK and PODCAST PLAYER of your choice. The transcripts of every episode is located at our website: www.psychederx.com Remember…
 
We talked before about the different ways to make a career in science. We've had people from finance, and entrepreneurs driving the start-up world. We've even had a scientific illustrator. There's one area of science and technology that we're covering for the first time today - this one is near and dear to our hearts because it's something that we …
 
The pandemic presented unique challenges that no organization could have foreseen and prepared for. One of the main challenges was continuing with normal business activities with zero or limited employees in the business premises. By leveraging cloud solutions that enable employees to work remotely, many companies were able to increase their overal…
 
EUDAMED Commission implementing regulation 2021/2078: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2078 EUDAMED webpage: https://ec.europa.eu/health/md_eudamed/udi_devices_registration_en EUDAMED Playground: https://webgate.training.ec.europa.eu/eudamed-play/landing-page#/ UDI/Devices guidance: https://ec.europa.eu/health/sites/d…
 
Recently the MDCG guidance for Medical Device classification was published. And I wanted to have someone to help us decode it. Frank Matzek accepted to share his knowledge as he worked on the consultation of this guidance and he can tell us if there are some specific elements to look at. The discussion of today will be mainly on the changes related…
 
Recently, one of our loyal listeners sent a very kind message. It was extremely appreciate of our PsychedeRx series and asked a key question about how we went about doing the music as they referred to. That's when I realized that what I had taken as a necessary and mandatory part of our podcast was appreciated by the listener. It was a very pleasan…
 
One of the most stressful situations in the medical device business is the selection and the work with Notified Bodies. Why? Because there are less than what we need and because it is difficult to budget their service. So I have invited the Head of the TÜV SÜD Healthcare Business Unit to tell us more about the Notified Body Situation. We will discu…
 
This re-run was triggered by a news article of a horrible event in Ecuador where a prison riot killed 68 people. Such type of events are becoming increasingly commonplace due to organised crime. The rioters and instigators must be dealt with appropriately to control the violence, but beyomnd that where does that leave us? We can take one stance, wh…
 
If you are a company buying products from a supplier and then putting your brand on it to sell it in Europe, then you are an Own Brand Labeller or Private Labeller, or Virtual Manufacturer. In this episode, we will discuss this business model and what are the options for you as this is not really possible under EU MDR 2017/745 or EU IVDR 2017/746. …
 
We always think that what is most important in QA RA is to know the regulation. NO!. What is most important is to be able to transmit this knowledge to the other colleagues within your company. But to do that you need to understand certain parameters and this is what we will discuss today with Lesley Worthington. This podcast will help you improve …
 
Specialization was a concept that was reserved for the most sensitive industries, such as the medical industry. However, technological advancement and the rise of specialized software platforms have led to a need for specialization in other areas such as the product design field. This has also been motivated by the need to create the most compellin…
 
In this episode of the Podcast we will review: IVDR proposal to delay transition periods Cobalt on medical devices as CMR Artificial Intelligence MDCG guidance Notified Body overview Check links below Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years wit…
 
It's the climate change summit week. So in preparation for everyone, we wanted to re-run this crucial episode that we hope everyone gets to listen to. She gives a personal viewpoint as a scientist, coming from a coal-mining family and being the first graduate in her family to going on to be the Vice-Provost and Chief Research Officer of Villanova U…
 
It's the start of Season 4 of SKRAPS. So first, credit where it is due, thanks so much for the support! Have you ever wondered where the food you eat comes from? No, we do not talk about your carbon footprint or the location of the farm Food and flavour evokes a strong sense of nostalgia, likes and dislikes in our mind so much so that a particular …
 
A few weeks ago, we were surprised to hear that the EU Commission issued a proposal to delay some products from applying IVDR 2017/746 by my 26th, 2022. So we decided to discuss this proposal with Erik Vollebregt and see how this should be interpreted as this is not a postponement that is proposed but more some phase application per product class. …
 
In this episode, we will discuss CMR which are some substances that can be dangerous for your health. They are classified by legislation and we will explain to you what you should do. Ana Luiza Cassin Duz, Clinical Specialist will help us to define what are the MDR requirements and how you can follow the rules and be compliant. In a previous episod…
 
Recently EUDAMED made a major Update which was the release of the Device registration module. This is something that all Medical Device manufacturers need to listen to as this may impact their workload. Richard Houlihan from Eudamed.com accepted to come and tell us more about this update and provide you also with some advice on how to manage it. So…
 
If you’ve listened to the PsychedRx series, or ever contemplated experiencing psychedelics, you’ve probably asked yourself what a trip is really like. Well, I’d very much like to tell you what it’s like, but it’s much like trying to describe an exact shade of purple velvet. It’s deep, rich, bright, dark, it changes as the light shifts. When you tou…
 
October 4, 2021 marked the announcement of the Nobel Prize in Physiology and Medicine to Dr. David Julius and Dr. Ardem Parpoutian. This episode goes behind the relevance of their findings and why it is such an important moment for a field that brings together biology, physics, chemistry and medicine. Key Reviews to dig into: TRP channels: Click he…
 
The advancement of technologies such as 5G, VR, and AI has introduced another dimension for companies to compete on. These technologies were non-existent in the consumer market just two decades ago; back then, companies only had to deal with complexity related to customers’ need for customization. Manufacturers are now embracing solutions such as d…
 
Here are all the topics that we will cover during this regulatory update. Don’t forget to contact easy medical device if you need an EU-authorised representative, a Swiss representative or a UK-responsible person. HOT TOPIC Implementing Rolling Plan: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_rolling-plan_en.pdf EUROPA IVDR e…
 
Recently MDCG issued the guidance on Article 16 of the EU MDR & IVDR. This provided some surprises. So now in certain circumstances, some importers or distributors will need a Notified Body for their products. Erik Vollebregt from Axon Lawyers will explain to us those cases and why this is important that importers and distributors are becoming on t…
 
Hello all, This is JoJo, your friend and co-host of SKRAPS. I grew up around construction. Tradesmen and experts at the crafts of building and repairing homes were omnipresent in my childhood. From a very young age, I knew more about framing than I did about Barbie dolls. I was comfortable in the world of power tools and knew the importance of “mea…
 
Join us to listen to the bi-weekly news round up on all things #NeuroTech and #BioelectronicMedicine. This week we talk about academic news with Cleveland NeuroTech Entrepreneurs workshop, UConn hiring spree in Engineering with focus on NeuroTech. On industry side, we cover Rune Labs, Tivic Health, Opinions on Nyxoah and their FDA breakthrough desi…
 
Clinical Data is key for the Medical Device Regulation MDR 2017/745. Today on this Podcast Episode, I have invited Jon Bergsteinsson from Smart Trial. And we will discuss Digital tools to collect data. History of Clinical Data Collection Difference between Big and small companies Use of CRO for collecting data Difference on Clinical Investigation a…
 
Over the ten episodes in this series, it’s clear that we are enthusiastic about the future of psychedelic medicines. There are so many potential applications for responsible, physician-assisted therapies that it almost seems as though psychedelics are a silver bullet, or a little black dress - perfect for any occasion and applicable to myriad disea…
 
Visualization makes it possible to view new product designs before the first prototype is created. This makes it easier for customers to understand what they’ll get once the production starts and it also gives them an opportunity to recommend changes to their product at no cost. As the need for customization continues to increase product complexity…
 
We are at 9 months of the EU IVDR 2017/746 date of application. So let’s t talk of the Transition period for such products. We have done that also for MDR 2017/745 when the date was nearly due. So today we’ll tell you about: Differences between IVDD 98/79/EC and IVDR The Hard Transition Period – The Soft Transition Period The UDI transition period …
 
First of all, I am not encouraging anyone to sue anyone. This is only educative content to know what is possible and what is the best strategy to do it. We will talk about the reason one company would sue its Notified Body and also about the good method and the bad method to do it. Some of the discussions are based on real-life experience. Anyway, …
 
New molecules, new IP, new opportunities. How can investors be induced to support the massive, but necessary funds required to support the important and carefully regulated research necessary to bring psychedelic therapies to market. Not to be crass, but if something isn’t going to bring a profit, it’s unlikely to receive much funding, regardless o…
 
This month we will cover a lot of specific rules that are applied in some countries: USA UK France Finland Switzerland And then we’ll look at Events planned, Notified Bodies, MDCG guidances released, and the Podcast episodes. Enjoy! Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. A…
 
Mushrooms changed the world in the 20th century, some say. Others say, psychedelics are older than humankind. But instead of synthesising molecules and providing it people in a clandestine manner, what if, proper systematic drug discovery and development was done to make psychedelics better? In this penultimate episode of PsychedeRx, we explore a f…
 
Software as a Medical Device is really a difficult topic. First, because it is quite new in the EU Regulation, and second because we cannot make a generality and should consider each software one by one. In this episode, we asked directly a Notified Body to tell us exactly how we should view this field and what are the tips or warnings. So I have i…
 
Let’s describe to you the life of a Healthcare industry consultant with Smahan Toughrai. Within this episode, we will ask the question like: Why would we choose a consultant job? Should people have a certain skill to be a good consultant? Is the salary a good motivation to be a consultant? Is it better to work for a small company or a multinational…
 
Zeus gave Sisyphus the eternal punishment of forever rolling a boulder up a hill in the depths of Hades for his crimes of being a trickster and twice cheating death. “Then I witnessed the torture of Sisyphus, as he wrestled with a huge rock with both hands. Bracing himself and thrusting with hands and feet he pushed the boulder uphill to the top. B…
 
JoJo and I do a fortnightly (bi-weekly) newshour session on all things Neurotech spanning the academic and industry updates. This week we covered a few updates. Most important of all, it is the first women led chairing of Gordon Research Seminar Series as an add-on for Neuroelectronic Interfaces GRC. One of the co-chairs, Nikki Pelot joined us to g…
 
After few months of MDR, I proposed TÜV SÜD share with us the most common mistakes they find during their audits. And Martin Witte accepted to summarize some of them. So in this episode, you will hear the TOP 3 issues that are discovered so you can be prepared for it. You will see that some of them are obvious and others are more subtle. Administra…
 
Mike Jay is a renowned cultural historian and author of 4 fine books. We recently invited Mike to join us on our SKRAPS club session on Clubhouse app. We were also joined by Krish Ashok on the stage. Krish is the author of Masala Lab, a book on the science of Indian cooking. Mike's website: www.mikejay.net Find us on ClubHouse…
 
In today’s fast-moving world, change is inevitable for any business that wishes to remain relevant. For growth-oriented companies, change presents an opportunity to build sustainable products as well as meet more of their customers’ needs. The heavy machinery industry is adopting changes in the design and development of their product to meet the de…
 
On the agenda for this month Episode we will talk about the latest news and here are few topics that I will present to you: Team-NB Position Paper Harmonized Standards Free ISO standards MHRA guidance on Software as Medical Devices Training EU MDR Green Belt in August Notified Bodies situation MDCG guidances Easy Medical Device Podcast episodes Don…
 
Within this Masterclass, I will explain to you how to implement a vigilance reporting system with all the links for all the documents we talk about. Vigilance reporting is a system that you need to have in place for your Quality Management System even if you are still MDD compliant. If you get a serious incident or a Field Safety Corrective Action …
 
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…
 
A cast will help a broken bone to heal, a tourniquet will help to stop the bleeding in a limb, an aspirin will alleviate a headache, time (and ice cream) will help to heal a broken heart. But how do you heal a broken mind? Post Traumatic Stress Disorder (PTSD) is but one of the psychiatric indications with inadequate, frequently ineffective treatme…
 
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…
 
Every day, we’re inching closer and closer to the type of “future” we see in the movies. Cars can drive themselves and we can command playlists and order groceries with voice commands. Taking us one step closer is a device from technology company 4tiitoo that allows us to actually move things with our eyes. Today’s guest is Stephan Odörfer, Co-foun…
 
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…
 
We discuss previously underappreciated personal stories of how the Psychedelic Renaissance was sparked since 1971. Description: 1971 was the year when drug prohibition came into force. Did we tell you the story of how the tables were turned against the prohibition of drugs? Or did we tell you the hurdles that were needed to be overcome. Well, that'…
 
Loading …

Quick Reference Guide

Copyright 2022 | Sitemap | Privacy Policy | Terms of Service
Google login Twitter login Classic login