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Listen Medical Device Regulation and Standards
The implementation of Unique Device Identification (UDI) has already transformed regulatory compliance in the medical device industry. Now,...
Achieving CE marking under the EU MDR is a major milestone for medical device manufacturers. However, for AI-based medical devices, certific...
Many medical device companies believe they have a compliant Quality Management System (QMS). On paper, everything looks perfect:• Procedures...
Artificial Intelligence is rapidly transforming the medical device industry, enabling smarter diagnostics, predictive analytics, and persona...
Medboard EU UK Events RoW Your advertisement must contain: For example, you must not: Podcast Service The post Medical Device News APRIL 202...
The medical device industry is evolving rapidly, driven by stricter regulations, innovation, and global market challenges.To help you stay a...
The upcoming EUDAMED deadline on May 28, 2026, marks a major shift in how regulatory data is managed under the EU MDR and IVDR. While many c...
Medboard Europe Team NB UK Solutions RoW Podcast Social Media to follow The post Medical Device News March 2026 Regulatory Update appeared f...
The global medical device regulatory environment is complex, often requiring manufacturers to repeat similar submissions and audits across m...
IEC 60601 has been central to medical electrical equipment safety for decades. From the prescriptive approach of the 2nd edition to the risk...
In Software as a Medical Device (SaMD), defect management is far more than tracking bugs. It is a structured, risk-driven process that direc...
SPONSOR EUROPE  New Harmonization Standards –  Implementing Decision 2026/193:  The conference will feature three break...
Validation is a cornerstone of medical device compliance — yet it remains one of the most challenging areas for manufacturers. In this podca...
For decades, medical device manufacturers in the US relied on 21 CFR 820 (QSR) — a system known for being procedural and checklist-oriented....
Design History File (DHF) remediation is rarely planned — yet it is a recurring challenge for many medical device manufacturers, especially...
Social Media to follow The post Medical Device News January 2026 Regulatory Update appeared first on Medical Device made Easy Podcast . hamz...
Verification & Validation (V&V) plays a central role in ensuring that medical devices are safe, effective, and compliant — yet it re...
As the year closes, this special podcast episode offers a comprehensive overview of what happened at Easy Medical Device in 2025 and the key...
The European medical device sector is a vital pillar of healthcare innovation, employing over 930,000 people and representing a market of ap...
Clinical Evaluation has become one of the most critical — and challenging — domains under the EU MDR. But how does one build real expertise...
Medboard Europe UK Standard EasyIFU Rest of the World Argentina Canada Brazil: Podcast Podcast Nostalgia – Let’s review previous...
Becoming a Lead Auditor is one of the most valuable career steps for quality and regulatory professionals in the MedTech sector. Lead Audito...
The long-awaited revision of ISO 10993-1 is almost here – and the MedTech community is full of questions.Will we need to retest everything?I...
In this long-form interview, Helene Quie, founder of Qmed Consulting, shares an inside look at nearly 20 years of experience in clinical and...
MedBoard EU Service Magazine ROW PODCAST Social Media to follow The post Medical Device News November 2025 Regulatory Update appeared first...
Artificial Intelligence is reshaping the world of Quality and Regulatory Affairs.In this podcast episode, Hatem Rabeh joins to demystify how...
US Government Shutdown – What the FDA Can Still Be Doing? When the U.S. government experiences a shutdown, the consequences ripple across ev...
Real-World Evidence (RWE) is transforming how regulators evaluate medical devices — but many manufacturers still struggle to use it correctl...
Since the implementation of EU MDR 2017/745, clinical evidence has become one of the biggest challenges for medical device manufacturers — a...
The La Rentrée du DM 2025 conference brought together regulators, manufacturers, and industry experts to discuss the evolving landscape of E...
Medboard Europe Switzerland UK Magazine Events EasyIFU ROW Podcast Easy Medical Device Service Social Media to follow The post Medical Devic...
Post-Market Surveillance for Software & AI Devices – A QA/RA Guide Software evolves with updates. AI models may even change with real-wo...
The journey from a successful surgical career to the leadership of a medical company is far from ordinary. Yet for Prof. Marc Possover, this...
Cybersecurity in Medical Devices – A QA/RA Perspective Cybersecurity is often seen as an IT or engineering issue—but in reality, regulators...
Medboard EUROPE UK Switzerland Magazine Podcast: REST OF THE WORLD The post Medical Device News September 2025 Regulatory Update appeared fi...
Artificial Intelligence is no longer just a buzzword — it’s already finding its way into Quality Assurance (QA) and Regulatory Affairs (RA)...
Managing Software Updates in Medical Devices: Best Practices & Pitfalls In the world of medical devices, software updates are never just...
From Zero to One: Mastering Client Collaboration in ConsultingStarting your consulting journey can feel overwhelming—finding clients, buildi...
Have you ever wondered what it’s really like to work as a medical device consultant or ISO 13485 auditor? In this episode of the Medical Dev...
In our latest podcast, we dive deep into the recruitment world with Mitch, a founder and specialist recruiter in Quality Assurance & Reg...
Everything You Need to Know About EU Regulation 2025/1234 and the Future of eIFU for Medical Devices On July 16, 2025, a pivotal regulatory...
Quality & Regulatory in MedTech – Interview with Pardeep Kaur  Background: From IT in India to MedTech in Norway  Day-to-Day a...
Guest: Stefan Bolleininger  Title: From Zero to One: Creating your Consulting Firm  Logo: Be on Quality   Telling the st...
Medboard: https://www.medboard.com/ EUROPE UK ROW Podcast The post Medical Device News JULY 2025 Regulatory Update appeared first on Medical...
From Zero to One: SaaS Founder’s First Five Years with Ivan Perez Chamorro 🎧💡 In this exciting episode of the Easy Medical Device Po...
🎙️ Risk Grading Gone Wrong: How to Fix Your Severity, Occurrence & Detection Strategy Before Your Notified Body Does 🩺 Risk Management...
In this episode, Anindya Mookerjea will share with us his knowledge on Software Testing. We will review the basics and help you with being c...
episode 339 Medical Device News JUNE 2025 Regulatory Update monir el azzouzi easy medical device The post Medical Device News JUNE 2025 Regu...
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many...
In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with...