Shows / Medical Device made Easy Podcast
Episodes
- Medical Device made Easy Podcast
We Didn’t Know We Needed to Be a Medical Device” – Our Journey to CE Marking
From Virtual Reality Innovation to Medical Device Compliance: The Story of Pedro Thomaz and Revert Many healthcare technology startups begin with a simple…
- Medical Device made Easy Podcast
Can AI Really Write Your Clinical Evaluation Report?
Exploring AI-Assisted Clinical Evaluation with Ethan Drower from CiteMed Artificial Intelligence is changing how medical device companies approach…
- Medical Device made Easy Podcast
AI Agents for Your Medical Device Business: Where Do You Start?
Small Business, Smart Start: AI Without Complex Infrastructure Artificial Intelligence is creating new opportunities for businesses to improve productivity…
- Medical Device made Easy Podcast
Medical Device Regulatory Update – October 2026
October brings another important round of regulatory developments for the medical device and IVD industry. From updated IVD classification guidance in Europe…
- Medical Device made Easy Podcast
AI Is Already Inside Your QMS — But Is It Under Control?
Artificial Intelligence may already be part of your Quality Management System, even if your organization has never formally implemented an AI tool. Regulatory…
- Medical Device made Easy Podcast
Vertical Slicing for Complex SaMD Development
Developing complex Software as a Medical Device (SaMD) can quickly become challenging. Requirements, software architecture, dependencies, risk management…
- Medical Device made Easy Podcast
Why Management Doesn’t Listen to Quality—and How to Change That
Quality and Regulatory professionals often find themselves in a frustrating position. They identify a problem, explain the compliance risk and recommend an…
- Medical Device made Easy Podcast
Your Technical Documentation Has All the Documents… So Why Isn’t It Ready?
A company says its Medical Device Technical Documentation is 90% or 95% ready. The Risk Management File exists. The Clinical Evaluation is complete. Testing…
- Medical Device made Easy Podcast
Medical Device Regulatory Update: July & August 2026
Medical device regulation continues to evolve across multiple markets. For manufacturers, the challenge isn’t simply following every new…
- Medical Device made Easy Podcast
From Verification & Validation to Global Market Access | V&V, DHF & IMDRF
Developing a medical device successfully requires several pieces to work together. Manufacturers must demonstrate that the product meets its requirements…
- Medical Device made Easy Podcast
Regulatory Strategy & Market Access | Intended Use & Master UDI-DI
Bringing a medical device to market requires more than achieving regulatory approval. The decisions made early in product development can influence…
- Medical Device made Easy Podcast
Building a Strong Quality Management System: From Documentation to Real Compliance
Having an ISO 13485 Quality Management System in place does not automatically mean that your quality processes are effective. A strong QMS should help an…
- Medical Device made Easy Podcast
Quality & Compliance: Building Stronger Medical Device Quality Systems
Quality and regulatory compliance are fundamental to bringing safe and effective medical devices to market. As regulations continue to evolve and technologies…
- Medical Device made Easy Podcast
Your Risk Management File Is Probably Fiction
What would happen if your Risk Management File disappeared tomorrow? Would your medical device suddenly become less safe? For many organizations, the answer is…
- Medical Device made Easy Podcast
The Audit Readiness Myth: Why Most Startups Aren’t As Prepared As They Think
Many medical device startups assume they’re audit ready because they have documented procedures, completed templates, and a Quality Management System in…
- Medical Device made Easy Podcast
The FDA Clearance Journey: What Nobody Tells Medical Device Startups
For many medical device startups, obtaining FDA clearance seems like a clear, linear process. Identify a predicate device. Prepare your documentation. Submit…
- Medical Device made Easy Podcast
The Audit Went Perfectly… So Why Are We Still in Trouble?
For many medical device companies, a successful audit is seen as the ultimate proof that their Quality Management System is performing well. Few or no…
- Medical Device made Easy Podcast
Medical Device News July 2026 Regulatory Update
Stay up to date with the latest EU MDR, IVDR, UK MDR and Swiss Medical Device regulations. In this episode we cover: Well-Established Technologies (WET)…
- Medical Device made Easy Podcast
“We’ve Never Had a Complaint” — The Most Dangerous Sentence in Medical Devices
At first glance, hearing “We’ve never had a complaint” sounds like excellent news. No customer dissatisfaction. No product issues. No safety…
- Medical Device made Easy Podcast
NC vs CAPA: Are You Opening the Wrong Records?
One of the most common sources of confusion in medical device Quality Management Systems is knowing when to open a Nonconformity (NC) and when to initiate a…
- Medical Device made Easy Podcast
Best of „AI CE marking“
Artificial intelligence is transforming healthcare, but developing an AI medical device is only part of the challenge. Manufacturers must also navigate…
- Medical Device made Easy Podcast
Medical Device News June 2026 Regulatory Update
Sponsor Medboard Medboard: https://www.medboard.com/ EUROPE Europe Starts Regulating the Regulators – Implementing Regulation (EU) 2026/977…
- Medical Device made Easy Podcast
FEEDBACK AFTER 3 MONTHS OF THE NEW FDA QMSR IS IN PLACE
The FDA’s new Quality Management System Regulation (QMSR) officially became effective on February 2nd, 2026, replacing the legacy Quality System Regulation…
- Medical Device made Easy Podcast
How can a proper Intended Use save your device?
A medical device’s intended use is not just a regulatory formality — it is the foundation of the entire product strategy. In this podcast episode, Monir El…
- Medical Device made Easy Podcast
Medical Device News May 2026 Regulatory Update
Sponsor: Medboard https://www.medboard.com/ Europe EUDAMED: It’s Go Time -May 28th 2026 for New Products…
- Medical Device made Easy Podcast
Can You Certify an LLM-Driven Medical Device?
Large Language Models (LLMs) such as ChatGPT, Gemini, and Claude are rapidly transforming digital healthcare. From clinical decision support to medical…
- Medical Device made Easy Podcast
Master UDI-DI: The New Layer Many MedTech Companies Don’t Understand
The implementation of Unique Device Identification (UDI) has already transformed regulatory compliance in the medical device industry. Now, Europe is…
- Medical Device made Easy Podcast
Life After CE Marking: Why AI Medical Devices Need Continuous Monitoring
Achieving CE marking under the EU MDR is a major milestone for medical device manufacturers. However, for AI-based medical devices, certification is not the…
- Medical Device made Easy Podcast
The Fake QMS Problem: Why Your ISO 13485 System Will Fail an Audit
Many medical device companies believe they have a compliant Quality Management System (QMS). On paper, everything looks perfect: • Procedures are written •…
- Medical Device made Easy Podcast
AI Medical Devices: What Notified Bodies Really Look For
Artificial Intelligence is rapidly transforming the medical device industry, enabling smarter diagnostics, predictive analytics, and personalized healthcare…
- Medical Device made Easy Podcast
Medical Device News APRIL 2026 Regulatory Update
Medboard Sponsor: Medboard: https://www.medboard.com/ EU Extension of WET Class Iib – A new list with new products mentioned…
- Medical Device made Easy Podcast
These 3 podcasts will change how you see MedTech
The medical device industry is evolving rapidly, driven by stricter regulations, innovation, and global market challenges. To help you stay ahead, we’ve…
- Medical Device made Easy Podcast
EUDAMED Deadline 2026 – 7 Steps Every MedTech Company Must Prepare
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 companies believe…
- Medical Device made Easy Podcast
Medical Device News March 2026 Regulatory Update
Medboard Sponsor: Medboard: https://www.medboard.com/ Europe Pharmacist are distributors – French guide issued to educate them…
- Medical Device made Easy Podcast
IMDRF & Regulatory Reliance Explained: The Future of Global Medical Device Approvals
The global medical device regulatory environment is complex, often requiring manufacturers to repeat similar submissions and audits across multiple countries…
- Medical Device made Easy Podcast
IEC 60601 – From 2nd to 4th Edition: What Manufacturers Must Know
IEC 60601 has been central to medical electrical equipment safety for decades. From the prescriptive approach of the 2nd edition to the risk-based philosophy…
- Medical Device made Easy Podcast
Defect Management in SaMD — From Chaos to Control
In Software as a Medical Device (SaMD), defect management is far more than tracking bugs. It is a structured, risk-driven process that directly impacts patient…
- Medical Device made Easy Podcast
Medical Device News February 2026 Regulatory Update
SPONSOR Medboard: https://www.medboard.com/ EUROPE New Harmonization Standards – Implementing Decision 2026/193…
- Medical Device made Easy Podcast
Validation & Supplier Management in MedTech
Validation is a cornerstone of medical device compliance — yet it remains one of the most challenging areas for manufacturers. In this podcast episode, Simon…
- Medical Device made Easy Podcast
QMSR Is Coming: Why FDA Inspections Will Change Completely in 2026
For decades, medical device manufacturers in the US relied on 21 CFR 820 (QSR) — a system known for being procedural and checklist-oriented. But starting…
- Medical Device made Easy Podcast
How to Remediate a Design History File (DHF)
Design History File (DHF) remediation is rarely planned — yet it is a recurring challenge for many medical device manufacturers, especially during audits…
- Medical Device made Easy Podcast
Medical Device News January 2026 Regulatory Update
Medboard: https://www.medboard.com/ Europe EMD Mag Issue 3 – For QA RA people: https://easymedicaldevice.com/emd-mag/ EU to simplify MDR and IVDR –…
- Medical Device made Easy Podcast
Verification & Validation Explained — A Practical Conversation with Aaron Joseph
Verification & Validation (V&V) plays a central role in ensuring that medical devices are safe, effective, and compliant — yet it remains one of the most…
- Medical Device made Easy Podcast
Last Podcast of the Year – Easy Medical Device | Year in Review & What’s Next
As the year closes, this special podcast episode offers a comprehensive overview of what happened at Easy Medical Device in 2025 and the key priorities shaping…
- Medical Device made Easy Podcast
Simplifying EU Medical Device Regulations: Understanding the 2025 Proposal
The European medical device sector is a vital pillar of healthcare innovation, employing over 930,000 people and representing a market of approximately €170…
- Medical Device made Easy Podcast
From Engineer to Clinical Evaluation Expert – The Journey of Florian Tolkmitt
Clinical Evaluation has become one of the most critical — and challenging — domains under the EU MDR. But how does one build real expertise in this field? In…
- Medical Device made Easy Podcast
Medical Device News DECEMBER 2025 Regulatory Update
Medboard Europe 48% disruption in the EU – I hope you are all healthy: https://health.ec.europa.eu/document/download/13b2c812-b144-4489-af1f-e76af5bc97fd_…
- Medical Device made Easy Podcast
How to become a LEAD AUDITOR made Easy
Becoming a Lead Auditor is one of the most valuable career steps for quality and regulatory professionals in the MedTech sector. Lead Auditors play a critical…
- Medical Device made Easy Podcast
What is changing with the new ISO 10993-1 version 2025
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? Is this a complete…
- Medical Device made Easy Podcast
From Zero to One: The journey of a CRO with Helene Quie
In this long-form interview, Helene Quie, founder of Qmed Consulting, shares an inside look at nearly 20 years of experience in clinical and regulatory…
- Medical Device made Easy Podcast
Medical Device News November 2025 Regulatory Update
MedBoard EU Joint clinical assessment procedure – EU 2025/2086 regulation for reimbursement in the EU…
- Medical Device made Easy Podcast
Automatisation of your QA RA job with AI
Artificial Intelligence is reshaping the world of Quality and Regulatory Affairs. In this podcast episode, Hatem Rabeh joins to demystify how AI can be used —…
- Medical Device made Easy Podcast
US Government Shutdown – What FDA can still be doing?
US Government Shutdown – What the FDA Can Still Be Doing? When the U.S. government experiences a shutdown, the consequences ripple across every industry — but…
- Medical Device made Easy Podcast
Real-World Evidence (RWE): How to Use It Right for FDA and EU MDR Compliance
Real-World Evidence (RWE) is transforming how regulators evaluate medical devices — but many manufacturers still struggle to use it correctly. In this episode…
- Medical Device made Easy Podcast
Clinical Evidence under EU MDR – Why So Many Dossiers Fail (and How to Fix It)
Since the implementation of EU MDR 2017/745, clinical evidence has become one of the biggest challenges for medical device manufacturers — and a major source…
- Medical Device made Easy Podcast
Highlights from La Rentrée du DM 2025
The La Rentrée du DM 2025 conference brought together regulators, manufacturers, and industry experts to discuss the evolving landscape of European and global…
- Medical Device made Easy Podcast
Medical Device News OCTOBER 2025 Regulatory Update
Medboard Europe Too much Incomplete Tech File – Let’s explain to you how to do it…
- Medical Device made Easy Podcast
Post-Market Surveillance for Software and AI Devices
Post-Market Surveillance for Software & AI Devices – A QA/RA Guide Software evolves with updates. AI models may even change with real-world data. That makes…
- Medical Device made Easy Podcast
From Surgeon to CEO: Building NEUROGYN AG Professor Marc Possover’s Journey
The journey from a successful surgical career to the leadership of a medical company is far from ordinary. Yet for Prof. Marc Possover, this evolution felt…
- Medical Device made Easy Podcast
Cybersecurity in Medical Devices – What QA/RA Must Do Today
Cybersecurity in Medical Devices – A QA/RA Perspective Cybersecurity is often seen as an IT or engineering issue—but in reality, regulators and auditors turn…