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...
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20 of 424 episodesCan 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 ap...
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 impro...
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 g...
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 A...
Vertical Slicing for Complex SaMD Development
Developing complex Software as a Medical Device (SaMD) can quickly become challenging. Requirements, software architecture, dependencies, ri...
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 a...
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 c...
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 n...
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...
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 in...
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 s...
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 evolv...
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 organizat...
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 Ma...
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 docu...
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....
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: 🤝 Episode Sponsor Medb...
“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...
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 wh...