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MedTech Global Insights - 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.

Life Sciences Science Business Technology
Update frequency
every day
Average duration
3 minutes
Episodes
19
Years Active
2025
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Unlocking the UAE MedTech Market: A Deep Dive into the MOHAP Classification Letter and How Pure Global Streamlines Your Entry

Unlocking the UAE MedTech Market: A Deep Dive into the MOHAP Classification Letter and How Pure Global Streamlines Your Entry

This episode of MedTech Global Insights dives deep into a crucial, often underestimated step for entering the UAE's medical device market: obtaining a MOHAP classification letter. We explore why this…
00:03:24  |   Sat 06 Sep 2025
Cracking the UAE MedTech Market: A Pure Global Deep Dive into Medical Device Classification and MOHAP Strategy

Cracking the UAE MedTech Market: A Pure Global Deep Dive into Medical Device Classification and MOHAP Strategy

This episode of MedTech Global Insights delves into the specifics of the United Arab Emirates' medical device classification system, a critical hurdle for any company looking to enter this lucrative …
00:03:01  |   Fri 05 Sep 2025
Unlocking the UAE MedTech Market: A Pure Global Deep Dive into MOHAP Medical Device Registration and a Case Study on Avoiding Common Pitfalls.

Unlocking the UAE MedTech Market: A Pure Global Deep Dive into MOHAP Medical Device Registration and a Case Study on Avoiding Common Pitfalls.

This episode of MedTech Global Insights provides a strategic deep dive into the medical device registration process in the United Arab Emirates. We explore the regulatory landscape governed by the Mi…
00:03:25  |   Thu 04 Sep 2025
Navigating the MedTech Maze: How Pure Global Transforms Global Market Access with an AI-Powered, Unified Regulatory Strategy

Navigating the MedTech Maze: How Pure Global Transforms Global Market Access with an AI-Powered, Unified Regulatory Strategy

In this episode of MedTech Global Insights, we tackle the most significant hurdle facing MedTech and IVD companies today: navigating the treacherous landscape of global market regulations. We explore…
00:03:13  |   Wed 03 Sep 2025
Navigating the EU's IVDR Maze: A Survival Guide for IVD Manufacturers with Pure Global's Expert Insights

Navigating the EU's IVDR Maze: A Survival Guide for IVD Manufacturers with Pure Global's Expert Insights

In this episode of MedTech Global Insights, we dissect the monumental shift from Europe's IVDD to the new In Vitro Diagnostic Regulation (IVDR). We explore the seismic impact of the new risk-based cl…
00:03:30  |   Tue 02 Sep 2025
Unlocking Global MedTech Markets: The Pure Global Strategy for Choosing Your Medical Device Registration Consultant

Unlocking Global MedTech Markets: The Pure Global Strategy for Choosing Your Medical Device Registration Consultant

In this episode of MedTech Global Insights, we explore the critical role of a medical device registration consultant. Many innovative companies face the daunting challenge of navigating the complex w…
00:03:27  |   Mon 01 Sep 2025
First-in-Class Medical Device? Pure Global Explains How the FDA De Novo Pathway is Your Strategic Route to the US Market

First-in-Class Medical Device? Pure Global Explains How the FDA De Novo Pathway is Your Strategic Route to the US Market

This episode of MedTech Global Insights demystifies the FDA's De Novo classification pathway, a critical tool for innovators bringing novel, low-to-moderate risk medical devices to the U.S. market. W…
00:03:22  |   Sun 31 Aug 2025
Navigating Global MedTech Compliance: A Guide to Medical Device Registration with Pure Global

Navigating Global MedTech Compliance: A Guide to Medical Device Registration with Pure Global

In this episode of MedTech Global Insights, we demystify the complex process of medical device registration. We go beyond the basics to uncover the critical strategic missteps that can derail a produ…
00:03:44  |   Sat 30 Aug 2025
Navigating Global MedTech Compliance: A Pure Global Guide to Medical Device Registration Requirements

Navigating Global MedTech Compliance: A Pure Global Guide to Medical Device Registration Requirements

In this episode of MedTech Global Insights, we tackle one of the most significant challenges for MedTech and IVD companies: navigating the complex web of global medical device registration requiremen…
00:04:42  |   Fri 29 Aug 2025
Unlocking Europe: Your Strategic Guide to CE Marking for Medical Devices Under the MDR, from Technical Dossiers to Notified Bodies, Presented by Pure Global

Unlocking Europe: Your Strategic Guide to CE Marking for Medical Devices Under the MDR, from Technical Dossiers to Notified Bodies, Presented by Pure Global

In this episode of MedTech Global Insights, we demystify the complex process of obtaining a CE mark for medical devices under the European Union's stringent Medical Device Regulation (MDR). We move b…
00:03:19  |   Thu 28 Aug 2025
Mastering the FDA's Most Rigorous Hurdle: A Pure Global Deep Dive into the Premarket Approval (PMA) Process for High-Risk MedTech

Mastering the FDA's Most Rigorous Hurdle: A Pure Global Deep Dive into the Premarket Approval (PMA) Process for High-Risk MedTech

In this episode of MedTech Global Insights, we tackle the FDA's most stringent regulatory pathway: the Premarket Approval (PMA) process. Designed for high-risk, life-sustaining Class III devices, the…
00:03:52  |   Wed 27 Aug 2025
From Band-Aids to Pacemakers: Pure Global's Ultimate Guide to Medical Device Classification and Navigating Your Regulatory Journey.

From Band-Aids to Pacemakers: Pure Global's Ultimate Guide to Medical Device Classification and Navigating Your Regulatory Journey.

This episode of MedTech Global Insights dives into the most critical first step for any medical device manufacturer: classification. Discover why determining if your device is Class I, II, or III is …
00:03:42  |   Tue 26 Aug 2025
From Concept to Clearance: Pure Global's Expert Playbook for Avoiding Common FDA 510(k) Pitfalls

From Concept to Clearance: Pure Global's Expert Playbook for Avoiding Common FDA 510(k) Pitfalls

Navigating the FDA's 510(k) premarket notification process is a critical hurdle for most Class II medical device manufacturers seeking entry into the lucrative U.S. market. This pathway is designed t…
00:03:40  |   Mon 25 Aug 2025
Cracking the Code of FDA Medical Device Registration: A Pure Global Deep Dive into 510(k) vs. PMA Pathways for US Market Success

Cracking the Code of FDA Medical Device Registration: A Pure Global Deep Dive into 510(k) vs. PMA Pathways for US Market Success

This episode of MedTech Global Insights delves into the critical process of FDA medical device registration, the essential first step for entering the lucrative U.S. market. We break down the three c…
00:03:50  |   Sun 24 Aug 2025
Unlocking Global Markets for Orthopedic Implants: A Pure Global Guide to Navigating FDA, CE, and Emerging Market Regulations

Unlocking Global Markets for Orthopedic Implants: A Pure Global Guide to Navigating FDA, CE, and Emerging Market Regulations

In this episode of MedTech Global Insights, we explore the rapidly growing orthopedic implant market and the immense regulatory challenges that manufacturers face. With an aging global population dri…
00:03:21  |   Sat 23 Aug 2025
The Heart of MedTech Regulation: How Pure Global Navigates Cardiovascular Device Registration from 510(k) and PMA to Global Market Success

The Heart of MedTech Regulation: How Pure Global Navigates Cardiovascular Device Registration from 510(k) and PMA to Global Market Success

In this episode of MedTech Global Insights, we explore the high-stakes world of cardiovascular device registration. This sector sees a massive volume of regulatory submissions, from life-saving innov…
00:03:52  |   Fri 22 Aug 2025
The AI MedTech Revolution: Mastering Global Software as a Medical Device (SaMD) Registration Challenges with Pure Global's Expert Strategy.

The AI MedTech Revolution: Mastering Global Software as a Medical Device (SaMD) Registration Challenges with Pure Global's Expert Strategy.

As artificial intelligence and machine learning transform healthcare, Software as a Medical Device (SaMD) presents a massive opportunity. From diagnostic algorithms to digital therapeutics, these inn…
00:03:14  |   Thu 21 Aug 2025
Navigating the Post-Pandemic IVD Maze: A Pure Global Guide to Streamlining Global Regulatory Strategy and Market Access

Navigating the Post-Pandemic IVD Maze: A Pure Global Guide to Streamlining Global Regulatory Strategy and Market Access

The COVID-19 pandemic thrust the In-Vitro Diagnostic (IVD) industry into the global spotlight. This rapid ascent brought unprecedented opportunities but also triggered a wave of intense regulatory sc…

00:03:04  |   Wed 20 Aug 2025
Mastering Wearable Medical Device Registration: Pure Global's Guide to FDA Approval, SaMD, and Global Market Strategy

Mastering Wearable Medical Device Registration: Pure Global's Guide to FDA Approval, SaMD, and Global Market Strategy

In this episode of MedTech Global Insights, we explore the explosive trend of wearable medical devices. From smartwatches with ECG features to continuous glucose monitors, the line between consumer t…

00:03:19  |   Tue 19 Aug 2025
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