Medical Device made Easy Podcast

<p >The implementation of Unique Device Identification (UDI) has already transformed regulatory compliance in the medical device industry.</p> <p >Now, Europe is introducing an additional layer: Master UDI-DI — adding...

<p >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 end of the journey — it is only the beginning.</p> <p >In...

<p >Many medical device companies believe they have a compliant Quality Management System (QMS).</p> <p >On paper, everything looks perfect:<br>• Procedures are written<br>• Forms are available<br>• Risk management is...

<p >Artificial Intelligence is rapidly transforming the medical device industry, enabling smarter diagnostics, predictive analytics, and personalized healthcare solutions. However, with this innovation comes increased...

<p >Medboard</p> Sponsor: Medboard: https://www.medboard.com/ <p >EU</p> Extension of WET Class Iib – A new list with new products mentioned: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=PI_COM:C(2026)1809...

<p >The medical device industry is evolving rapidly, driven by stricter regulations, innovation, and global market challenges.<br>To help you stay ahead, we’ve gathered the most valuable insights from three MedTech...

<p >The upcoming EUDAMED deadline on May 28, 2026, marks a major shift in how regulatory data is managed under the EU MDR and IVDR.</p> <p >While many companies believe this transition is simply about uploading...

<p >Medboard</p> Sponsor: Medboard: https://www.medboard.com/ <p >Europe</p> Pharmacist are distributors – French guide issued to educate them...

<p >The global medical device regulatory environment is complex, often requiring manufacturers to repeat similar submissions and audits across multiple countries. This duplication slows innovation and delays patient...

<p >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 introduced in the 3rd edition, the standard has...

<p >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 safety, regulatory compliance, and product lifecycle...

<p >SPONSOR</p> Medboard: https://www.medboard.com/ <p >EUROPE</p> <p > New Harmonization Standards – Implementing Decision 2026/193: </p> https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600193...

<p >Validation is a cornerstone of medical device compliance — yet it remains one of the most challenging areas for manufacturers. In this podcast episode, Simon Foeger, Founder of SIFO MEDICAL, shares real-world...

<p >For decades, medical device manufacturers in the US relied on 21 CFR 820 (QSR) — a system known for being procedural and checklist-oriented.<br>But starting February 2nd, 2026, FDA will implement QMSR, changing not...

<p >Design History File (DHF) remediation is rarely planned — yet it is a recurring challenge for many medical device manufacturers, especially during audits, inspections, acquisitions, or regulatory framework...