Medical Device made Easy Podcast

In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with the EU MDR certification. The post How deepeye Medical overcame the AI ACT? appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Cecile van der Heijden will disclose all the secret of the EHDS or European Health Data Space law. The post Is EHDS dangerous for Medical Device manufacturers? appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Aouda Ouzza is helping us understand when the Regulatory Affairs person is needed during the design phase. The post When is Regulatory Affairs needed during Design? appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Claire Dyson will clarify to us what is the new PMS requirements from UK MHRA. The post What is the new UK Post-Market Surveillance Requirements? appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Adam Isaacs Rae is helping us to register our Medical Devices in Malaysia. We will review the requirements for it. The post How to register your Medical Device in Malaysia? appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Yassine Bader will explain to you the advantage or the risk of quitting your permanent job to become a consultant. The post Should you quit your job to become a consultant? appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Cyrille Michaud from MD101 will explain us how to prepare for Cybersecurity compliance for your medical device. The post How to satisfy Cybersecurity for FDA and EU? appeared first on Medical Device made Easy Podcast. hamza benafqir

Sponsor: Medboard Europe Registration ROW Podcast Social Media to follow The post Medical Device News April 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Darrin Carlson will explain to us what are the main issues that are discovered during FDA inspections and how to correct them. The post What are the TOP 3 FDA inspection issues? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News January 2025 Regulatory Update The post Medical Device News March 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Hatem Rabeh will explain to us what are Clinical Data and also if there is a chance for you to avoid Clinical Investigations The post How to avoid Clinical Investigation for your Device? appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Michelle Lott will walk us through the Breakthrough Device Program created by the FDA. Who can benefit from it? And what are the benefits? The post FDA: Advantage of the Breakthrough Device Program appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Bijan Elahi will share with us the methodology you should follow to start your Risk Management Project The post How and Who to build your Risk Management File? appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Mark Rogovoi will share his experience with Certification Bodies. The post The good, the bad and the ugly of certification bodies appeared first on Medical Device made Easy Podcast. hamza benafqir

Medboard EU Training Rest of the World: Podcast The post Medical Device News January 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, I will give you some advice on how to grow as a QA RA Manager. The post 6 Tips to Grow as a QA RA Manager appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Adam Isaac Rae will share with us is TOP 5 common NCs during an ISO 13485 audit. The post TOP 5 common NCs on an ISO 13485 audit appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Dr. Joan D’Souza will help us to do our PMS the right way when we have to deal with a Drug-Device Combination. The post How to perform your PMS for a Drug-Device Combination? appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Khanyisile Nkuku will share with us the way companies can register an medical device in South Africa. The post How to register a Medical Device in South Africa? appeared first on Medical Device made Easy Podcast. hamza benafqir

Stefan bolleininger will share with us information regarding Artificial intelligence and MDR. This presentation happened during Medica 2024. So if you have any questions you can ask ok the comments. […] The post Medica: AI & MDR FLIP THE COIN appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Monir El Azzouzi will summarize 2024 for Easy Medical Device and share projects for 2025. The post Easy Medical Device Great Summary 2024 appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Adnan Ashfaq will share with us the major pitfalls he experienced when dealing with Medical Device startups. The post What are the major pitfalls of Startups in Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir

MEDBOARD: https://www.medboard.com/ EUROPE SMARTEYE EVENTS TRAINING ROW • Webinar January 14, 2025 – https://www.fda.gov/medical-devices/cdrhnew-news-andupdates/webinar-final-guidance-marketing-submission-recommendations-predetermined-change-control-plan?utm_source=FDALinkedin PODCAST Social Media to follow The post Medical Device News December 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Maria Diez from CMGMedDev is explaining to us the PCCP tool for SaMD and why it can help a lot. The post PCCP – The Magic tool for SaMD in the US? appeared first on Medical Device made Easy Podcast. hamza benafqir

: In this episode, Beat Keller from SMDC in Switzerland will help us to setup the right tests for your alarm systems. And you’ll see that it is not so obvious. The post IEC 60601-1-8 How to test your Medical Device alarms? appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Monir El Azzouzi will help you build the perfect Quality Management System. He will give you his recipe to start the creation of a QMS and show you step by step what you should do. The post How to build the perfect Quality Management System? appeared first on Medical Device made Easy Podcast. hamza benafqir

Podcast: Is FMEA bad for your Risk Management? With Monir El Azzouzi and Rod Beuzeval The post Is FMEA bad for your Risk Management? appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Stefan Bolleininger will explain you can save money on your MDR or IVDR submission just by choosing the right MDR or IVDR code and by following some of his advice. The post How MDR and IVDR code can save you money? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medboard https://www.medboard.com/   EU   Training   Events MedtechConf events – Check the MAP   ROW Australia Mexico GMP for Mexico – Draft document: https://www.dof.gob.mx/nota_detalle.php?codigo=5734591&fecha=26/07/2024#gsc.tab=0   South Africa   PODCAST […] The post Medical Device News November 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

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. The post What does a strategy for regulatory compliance looks like? appeared first on Medical Device made Easy Podcast. hamza benafqir

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. The post What are the TOP 3 issues on CAPAs? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medboard: https://www.medboard.com/ EUROPE EVENTS NB ROW Middle East Northern America South America: PODCAST Social Media to follow The post Medical Device News, October 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Lucas Pianegonda will help us to select the right material for your medical device and answer questions that you maybe would love to hear his answer. We will also talk about sustainability for plastics. So, check this. The post How to select the best plastic for your Medical Device? appeared first on Medical Device made Easy Podcast. hamza benafqir

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. The post UK vs EU vs US – How to switch to another region easily? appeared first on Medical Device made Easy Podcast. hamza benafqir

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. The post How to do a PMCF Literature Search for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir

EU Switzerland Training Events: ROW Medical Device Live Expert: Podcast The post Medical Device News, Septembre 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

n 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. The post How to use AI GPT for your Quality and Regulatory work? appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Stephen O’Rourke that was not working within the Medical Device industry will share with us is journey from Zero knowledge in the field to running projects. Listen to his journey in case you are also willing to breakthrough the medical device field. The post How to go from Zero to Hero in Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir

: In this episode, I have invited Ralf Gansel to help us understand the process for Certification of your product and what is the lifecycle for it. We’ll discuss about Transfer or certificates, or notification of changes or why there is a renewal and not continuous surveillance… The post Manage the Transfer/Renewal/Surveillance/Change of your CE certificate appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Beat Keller will help you understand Harmonized Standards and how to use them and also how to do when there is no Harmonized Standards. So stay tuned. The post How to use Harmonized Standards for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir

TÜV SÜD is one of the main notified bodies. And they are celebrating their 100th Class D certificate. Andreas Stange will explain to us what they learned and how manufacturers can improve their certification process. The post IVDR Class D – Lesson learned from Notified Bodies appeared first on Medical Device made Easy Podcast. hamza benafqir

The EU MDR is in constant update and this change on the interruption of supply of medical devices should be integrated. The post EU MDR Major update: Interruption or Discontinuation of supply! appeared first on Medical Device made Easy Podcast. hamza benafqir

How to register your Medical Devices in the UAE with Ahmed Hendawy from Registitute and Monir El Azzouzi from Easy Medical Device The post How to register your Medical Device in the UAE? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Devices should follow regulations like EU MDR or IVDR but also some regulations that are also targeting some components like batteries. So for that there is EU Battery Regulation 2023/1542. Erik Vollebregt from Axon Lawyers will explain the impact of the regulation to your product. The post EU Battery Regulation – How to be ready? appeared first on Medical Device made Easy Podcast. hamza benafqir

The AI Act will be soon officially published even if we know the text will not change. So let’s help you to be prepared for its implementation. Fabien Roy will explain the challenges that he has recognized. The post AI Act – What are the challenges for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir

Medboard EU UK Swiss MEDTECH CONF LIVE SESSION US Australia Saudi Arabia Malaysia South Africa PODCAST Social Media to follow The post Medical Device News, July 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

As a Software developer, we need to understand what a Regulator can look at when you submit an AI/ML Model. Let’s listen to Richie Christian from Wega The post How to submit your AI/ML SAMD the right way? appeared first on Medical Device made Easy Podcast. hamza benafqir

The Notified Body is an important actor for Medical Devices that seek a CE certification under EU MDR and IVDR. In this Episode Thomas Lommatzsch from AFNOR will explain to us the difficult process of designation. The post AFNOR – How is a Notified Body designated? appeared first on Medical Device made Easy Podcast. hamza benafqir

If you are working within Surgical Instruments, or any products that need to be really clean prior to be sent, then this episode is for you. We discuss with Heena Thakkar what is the best way to manage cleaning validation. The post Cleaning Validation – How to select the worst case? appeared first on Medical Device made Easy Podcast. hamza benafqir

The post Medical Device News June 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir