x

75% of people globally want unbiased news (Pew Research) but are concerned they're not getting that.

Get balanced coverage with Symby. See how stories are covered across diverse outlets and spot when one side covers a story the other skips.

PODCAST

MedTech Global Insights

What"s next in the future of health? Welcome to MedTech Global Insights, the podcast dedicated to uncovering the most disruptive technologies and brilliant minds in the medical field. Whether you"re an industry professional, investor, or simply curious, subscribe for your dose of cutting-edge information and expert commentary.

science life sciences

All Episodes

04:12

From 21 CFR Part 820 to the QMSR: Pure Global's Deep...

MedTech Global Insights ·

2025/11/05

In this episode of MedTech Global Insights, we explore the monumental shift in the U.S. FDA's approach to quality systems for medical devices. We break down the transition from the long-standing 21 CFR Part 820 regulation to the new Quality Management System Regulation (QMSR), which harmonizes with the global standard ISO 13485. This isn't just a regulatory update; it's a fundamental change in how MedTech companies must approach their global compliance strategy.We move beyond the theory and dive

en

03:45

Mastering the MedTech Clinical Evaluation Report...

MedTech Global Insights ·

2025/11/04

In this episode of MedTech Global Insights, we demystify one of the most critical documents for European market access: the Clinical Evaluation Report (CER). Navigating the stringent requirements of MEDDEV 2.7/1 revision 4 is a major challenge for many MedTech companies, often leading to costly delays and rejections from Notified Bodies. We move beyond theory to provide actionable advice. This episode breaks down the four most common and critical failure points in CER writing: conducting a

en

03:35

The Ultimate Guide to EU MDR GSPR Compliance: How...

MedTech Global Insights ·

2025/11/03

This episode of MedTech Global Insights provides a deep dive into the General Safety and Performance Requirements (GSPR) of the EU MDR 2017/745, Annex I. We move beyond the checklist and explore the real-world challenges and regulatory expectations associated with these critical requirements. We uncover the most common pitfalls that can lead to Notified Body rejections, from inadequate justifications to insufficient clinical evidence. Learn how to build a GSPR compliance strategy that is robust,

en

03:49

MDSAP Explained: A Pure Global Guide to Participating...

MedTech Global Insights ·

2025/11/02

In this episode of MedTech Global Insights, we explore the Medical Device Single Audit Program (MDSAP), a revolutionary framework allowing MedTech and IVD manufacturers to satisfy the quality management system requirements of multiple countries through a single audit. We break down how this program can dramatically reduce audit fatigue and accelerate time-to-market. We detail the five core member countries—Australia, Brazil, Canada, Japan, and the U.S.—and explain the unique role MDSAP plays in

en

03:03

Unlocking US Market Access: A Pure Global Masterclass...

MedTech Global Insights ·

2025/11/01

As MedTech companies increasingly integrate artificial intelligence into Software as a Medical Device (SaMD), navigating the regulatory landscape becomes significantly more complex. The standard 510(k) pathway was not designed for adaptive algorithms, forcing the FDA and manufacturers to pioneer new approaches for ensuring safety and effectiveness throughout the product lifecycle.This episode delves into the specific challenges of securing 510(k) clearance for AI-enabled SaMD. We explore the FDA's

en

03:57

Unlocking Global MedTech Markets: A Deep Dive into...

MedTech Global Insights ·

2025/10/31

In this episode of MedTech Global Insights, we explore the new cornerstone of medical device security, the IEC 81001-5-1 standard. As healthcare technology becomes increasingly connected, the risk of cyber threats poses a significant danger to patient safety and can create major barriers to market entry. We break down what this standard means for manufacturers and why it's a critical component for regulatory approval in major markets like the U.S. and Europe.We discuss the standard's lifecycle

en

03:55

Cracking the Code: How Pure Global Helps SaMD...

MedTech Global Insights ·

2025/10/30

SaMD developers operate in a fast-paced, agile world, but the medical device industry is governed by the structured ISO 13485 standard. This episode demystifies how to merge these two worlds, transforming compliance from a roadblock into an integrated part of your development lifecycle. We explore practical, real-world strategies to build a robust Quality Management System that satisfies regulators without sacrificing the speed and flexibility essential for innovation in digital health.Imagine a

en

03:32

Unlocking MedTech Innovation: A Deep Dive into the...

MedTech Global Insights ·

2025/10/29

In this episode of MedTech Global Insights, we dissect the FDA's groundbreaking final guidance on Predetermined Change Control Plans (PCCPs) for AI/ML-enabled medical devices. We explore how this new framework moves beyond the traditional, rigid regulatory submission process, creating a streamlined pathway for manufacturers to innovate and improve their smart devices safely and effectively.Discover how a PCCP can unlock the full potential of your adaptive medical software. We'll use the example of

en

03:19

Cracking the Code: A Pure Global Deep Dive into...

MedTech Global Insights ·

2025/10/28

This episode of MedTech Global Insights delves into the rigorous clinical evaluation requirements for Software as a Medical Device (SaMD) under the European Union's Medical Device Regulation (MDR). We unpack the critical guidance from MDCG 2020-1, breaking down the three essential pillars of evidence required for your Clinical Evaluation Report: scientific validity, analytical validity, and clinical performance. We explore how the MDR elevates the burden of proof for software, moving it beyond

en

04:18

Cracking the Code: A Pure Global Guide to Securing a...

MedTech Global Insights ·

2025/10/27

Getting a CE Mark for a traditional medical device is challenging enough, but the complexity multiplies when Artificial Intelligence is involved. This episode of MedTech Global Insights breaks down the intricate process of securing a CE Mark for AI-powered medical devices under the stringent EU Medical Device Regulation (MDR) and the new EU AI Act. Imagine developing a groundbreaking AI algorithm that predicts patient outcomes with incredible accuracy, only to be stopped by a wall of regulations

en

03:55

The Pure Global MedTech Playbook: Unlocking FDA...

MedTech Global Insights ·

2025/10/26

The rise of AI is revolutionizing medical technology, but it presents a unique challenge for regulators. How does the FDA approve a device that is designed to change and learn over time? This episode of MedTech Global Insights dives deep into the FDA's framework for AI-powered medical software, offering a clear guide for innovators.We break down the essentials of the premarket submission process, moving beyond traditional models. We explore the critical concept of the Predetermined Change Control

en

03:48

Unlocking Global MedTech Markets with Pure Global: A...

MedTech Global Insights ·

2025/10/25

The global landscape for AI-enabled medical devices is rapidly evolving, with the two largest markets, the United States and the European Union, charting distinct regulatory courses. This episode of MedTech Global Insights provides a crucial breakdown of the fundamental differences between the FDA's iterative, change-oriented framework and the EU's comprehensive dual-system of the MDR and the new AI Act. We delve into the practical implications these differences have on product development, data

en

03:39

Navigating SaMD Risk: A Pure Global Guide to the...

MedTech Global Insights ·

2025/10/24

In this episode of MedTech Global Insights, we demystify the International Medical Device Regulators Forum (IMDRF) framework for Software as a Medical Device (SaMD). We break down the two-dimensional matrix used to classify SaMD risk, exploring how the significance of the information and the patient's condition determine whether your software is Class I or Class IV.We move beyond theory with concrete examples, from a simple skin-care app to a high-stakes AI diagnostic tool for cancer treatment

en

02:44

Beyond the Database: Why RegDesk Alternatives Are Key...

MedTech Global Insights ·

2025/10/23

Many MedTech and IVD companies rely on regulatory intelligence platforms like RegDesk for global expansion, only to discover that data alone doesn't get a product to market. This episode of MedTech Global Insights explores the critical gap between knowing the regulations and successfully executing a market submission. We break down the limitations of a platform-only approach and reveal what a truly effective alternative looks like.We move beyond simple databases to discuss an integrated strategy

en

03:02

Beyond Parexel: How Pure Global's AI-Powered Strategy...

MedTech Global Insights ·

2025/10/22

Expanding into international markets is a critical growth driver for MedTech and IVD companies, but the path is often blocked by the high costs, slow pace, and fragmented nature of traditional, large-scale CROs. This episode explores the common pitfalls of the legacy model, where companies are forced to navigate siloed teams and redundant processes, leading to significant delays and budget overruns.We then introduce a modern, agile alternative. Discover how an integrated, technology-first approach

en

03:11

Beyond the Behemoth: A MedTech Insider's Guide to...

MedTech Global Insights ·

2025/10/21

In this episode of MedTech Global Insights, we challenge the conventional wisdom of partnering with massive, one-size-fits-all CROs. While industry giants like ICON plc have their place, their pharma-centric models can stifle the agility and innovation that drive the MedTech sector. We explore the common frustrations of impersonal service, rigid processes, and spiraling costs that many device manufacturers face.We then uncover a more modern, efficient, and tailored approach to global market

en

03:17

Rethinking MedTech Regulatory Strategy: Why Companies...

MedTech Global Insights ·

2025/10/20

In the complex world of MedTech and IVD devices, selecting a regulatory partner is one of the most critical decisions for global growth. While large, established consulting firms like Pharmalex have long been the standard choice, many companies are now questioning if this model truly serves their needs. This episode explores the common challenges of working with industry giants, from communication gaps and slow processes to a costly, one-size-fits-all approach that stifles agility. We then

en

03:12

Beyond Freyr Solutions: How Pure Global's AI-Driven,...

MedTech Global Insights ·

2025/10/19

The global MedTech regulatory landscape is notoriously complex. While established firms like Freyr Solutions have been a traditional choice, the industry is shifting towards more agile, technology-driven partners. This episode explores the limitations of legacy models and introduces a modern framework for achieving faster, more cost-effective global market access.We delve into the concept of a "single process, multiple markets" strategy, powered by AI and a network of local experts. Discover how

en

03:23

Beyond Traditional MedTech Consulting: Why Companies...

MedTech Global Insights ·

2025/10/18

In this episode of MedTech Global Insights, we challenge the traditional, fragmented approach to regulatory consulting that often leaves MedTech and IVD companies struggling with delays, duplicated work, and inconsistent strategies across different markets. We explore the limitations of hiring multiple local consultants and introduce a modern, integrated alternative for achieving rapid and compliant global expansion. We delve into the evolution of regulatory affairs, moving beyond the old model to

en

03:22

Beyond MDSAP: Pure Global's Playbook for Smarter,...

MedTech Global Insights ·

2025/10/17

This episode of MedTech Global Insights challenges the one-size-fits-all approach to global regulatory compliance. We dive into the Medical Device Single Audit Program (MDSAP), exploring its benefits but also questioning whether it is the default best choice for every MedTech and IVD manufacturer seeking international growth.We uncover the powerful alternatives to MDSAP, focusing on a strategic, modular approach that can save you critical time and resources. Learn how to leverage your existing

en

79 results

Similar Podcasts

Classic Radio Science Fiction

solgoodmedia.com

Mission to Mars

Inception Point Ai

The 365 Days of Astronomy

365DaysOfAstronomy.org

Creek Devil

william Jevning

UFO Chronicles Podcast

Nik Hunter