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MedTech Resource Library

Resources Available

Axendia Report – Without PLI AI Stays a Pilot with PLI AI Scales

AI is reshaping MedTech, but scaling it remains a challenge. Learn how leading organizations are using Product Lifecycle Intelligence (PLI) to build trusted data foundations, move beyond pilots, and unlock enterprise-wide AI value.

DiscGenics® automates their quality processes

DiscGenics transformed its quality management process with ETQ Reliance, replacing manual workflows, streamlining document control, and supporting growth from research to commercialization.

Unlock Operational Efficiency for MedTech Service

Discover how digital innovation, AI, and predictive analytics are transforming MedTech service operations for better outcomes and efficiency.

Optimizing MedTech Manufacturing Operations

A comprehensive guide to overcoming regulatory hurdles, accelerating time-to-market, and reducing manufacturing costs through digital integration.

The Guide to Understanding the Impact on Cost of Poor Quality

Discover how modern quality management systems help manufacturers measure, reduce, and prevent costly quality failures. Gain visibility into the true Cost of Poor Quality to improve decision making, reduce waste, and protect revenue.

Evaluating AI in MedTech Regulatory Affairs

The current state of large language models makes them a useful accessory to human regulatory professionals, but can they replace experts on regulatory tasks? Read the study to find out.

Adapting to Regulatory Changes in the Life Sciences Industry

Adapting to Regulatory Changes in MedTech

Discover strategies for managing non-conformance in life sciences while adapting to evolving regulations. See how to integrate your quality system, risk management, and automation to more efficiently and effectively maintain compliance with global regulatory bodies.

Symmetry Surgical Uses ETQ Reliance Out‑of‑the‑Box to Streamline, Enhance Quality

How Did Symmetry Surgical Streamline and Enhance Quality?

Symmetry Surgical standardized quality processes and improved supplier collaboration to drive efficiency, visibility, and faster corrective actions. Learn how their centralized data and analytics enable faster decisions, stronger supplier collaboration, and measurable efficiency gains.

Mastering MedTech Intelligence - The Digital Thread

Mastering MedTech Intelligence: MedTech’s Digital Thread Journey

A series of interviews with industry leaders and innovators. This episode features Rene Zoelfl of PTC. Rene is the Global MedTech Advisor for PTC's MedTech Practice. Here, he shares his thoughts in a discussion around the Digital Thread...what it is and why the concept is vital for MedTech product teams to embrace as medical device product management accelerates to a future pace where data and access to it is the difference between success and failure.

Entrada-Lumitex Case Study

Building a Better Mousetrap for Global Reach

A four-decade journey took a bold new turn in 2019 when Lumitex strategically expanded into Mexico, with the help of Entrada Group, to lay the groundwork for a true global footprint.

Eastek Case Study

Becoming a Global Player in Manufacturing

This story analyzes Eastek’s journey and explore how this ambition wasn’t born from a desire to simply grow bigger—it was driven by a vision to serve clients more effectively in the Americas, Europe and Asia, protect their intellectual property (IP), and scale in ways that allowed them to compete with the largest electronics manufacturers in the industry.

Veeva 2025 Regulatory Affairs Benchmark Report

2025 Medtech Regulatory Affairs Benchmark

The 2025 Medtech Regulatory Affairs Benchmark reveals that many medtech companies lack confidence in their data’s completeness or accuracy and still rely heavily on manual processes to maintain compliance. This is largely underpinned by pervasive siloed processes, which make preparing regulatory submissions a resource-intensive endeavor.

essential guide to ISO 13845

Essential Guide to ISO 13485 Medical Devices Quality Management Systems

Are you ensuring your medtech products meet customer and regulatory requirements. ISO 13485 is the regulatory standard for MedTech Quality Management Systems. It emphasizes the importance for medical device manufacturers to develop high-quality products. Get your guide for building a comprehensive and compliant ISO 13485 Quality Management System.

Suntra POV whitepaper

Why Integrated Product Development is the Future of MedTech

New product development processes that are overly siloed are stifling MedTech innovation. Here’s why and the steps you can take to get engineering, clinical, regulatory, marketing, and manufacturing all working in parallel from day one.

PTC PLM+ALM Seamless Integration

Boost Product Quality with Integrated ALM and PLM

Whether you're managing complex product portfolios, navigating regulatory pressures, or striving to deliver higher customer satisfaction, this guide will help you understand the tangible benefits of integrating ALM and PLM.

PTC MedTech Buyers Guide

The MedTech Buyer’s Guide to Digital Transformation: Build a Smarter, Compliant Future

MedTech leaders face intense pressure to innovate rapidly while maintaining strict regulatory compliance, controlling costs, and improving patient outcomes. The global MedTech market is poised for significant growth. Yet, this opportunity comes with growing complexity. To succeed, MedTech organizations must move beyond fragmented systems and manual processes. View this guide to preparing for a more agile, resilient, and compliant future

REGULATORY REPORT 2024: Managing Global Regulatory Strategy & Compliance: Assessing Status, Gaps & Needs

An April 2024 survey of medical device regulatory professionals illustrates potential regulatory fatigue. See how resource constraints, ever changing global policy, and an underutilization of technology/digital process are impacting internal burden and fatigue and where implementing new regulatory strategies, upgrading organizational expertise, adding outsourced regulatory services are helping teams cope.

RIM Buyers Guide

RIM Buyers Guide for MedTech

If you’re considering a RIM system, it’s critical to determine the right scope, software capabilities, and balance between cost and value. Learn how to evaluate each piece with this RIM buyer’s guide for medtech.

EU MDR Checklist

EU MDR: Technical Documentation Checklist For Medical Device Manufacturers

Explore our EU MDR Checklist designed to help you navigate EU MDR compliance. This practical tool guides you through essential steps to adapt your processes and ensure documentation meets regulatory standards. Start your compliance journey with confidence.

Supply Chain Guide

The Essential Guide to Strategic Supplier Management for Medical Devices

Sponsored By Velosio

Medical Device Supply Chain Struggles? Download our FREE guide and discover how strategic supplier management builds resilience for a reliable flow of critical devices. We delve into the industry's unique challenges – strict regulations, quality needs, and constant innovation.

Addressing engineering challenges in point-of-care diagnostic devices

Addressing engineering challenges in point-of-care diagnostic devices

Sponsored By Flex

Discover what to consider when designing and manufacturing point-of-care diagnostic devices, including ensuring measurement accuracy and reliability, user-friendly operation, and scalable production with validated manufacturing processes.

Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership

Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership

Sponsored By Celegence

Download this case study for insights on optimized regulatory processes via tech-enabled services from Celegence. Acumed made their MDR compliance a success by boosting efficiency, saving time, and streamlining collaboration.

The ultimate guide to the EU MDR and IVDR GSPR, 2nd Edition

The ultimate guide to the EU MDR and IVDR GSPR, 2nd Edition

Sponsored By Rimsys

This comprehensive ebook breaks down the general safety and performance requirements for both the EU MDR and IVDR and includes tables comparing the EU MDD and IVDD Essential Principles with MDR and IVDR General Safety and Performance Requirements.

Crossing the eSTAR Chasm- The First MedTech Benchmark Report on FDA's 510(k) eSTAR Mandate

Crossing the eSTAR Chasm – The First MedTech Benchmark Report on FDA’s 510(k) eSTAR Mandate

Sponsored By Essenvia

In this groundbreaking report, Essenvia shines a first-ever light on regulatory professionals' preparedness, benchmarks, and best practices for embracing eSTAR and overcoming the challenges MedTech companies face in adopting the new mandate.

5 eSTAR Challenges MedTech Regulatory Teams Must Overcome

5 eSTAR Challenges MedTech Regulatory Teams Must Overcome

Sponsored By Essenvia

This paper will educate and prepare medical device manufacturers, regulatory affairs leaders, and regulatory consultants to effectively transition their processes, resources, and operations to seamlessly adopt the eSTAR as the new submission standard.

How redesign can help meet sustainability demands for medical devices

How redesign can help meet sustainability demands for medical devices

Sponsored By Flex

Redesign using Design for Environment principles can help medtech companies meet sustainability demands for their devices. See how to analyze and use eco-smart designs that account for sustainable materials, product durability, and improved energy efficiency.

How to Achieve Optimal Weighing Performance with Lab Balances

How to Achieve Optimal Weighing Performance with Lab Balances

Sponsored By Sartorius

Are you interested in how to achieve optimal weighing results in your medical devices production? Follow the subsequent tips and profit from highly reliable weighing results .

Better device outcomes through better data

Better device outcomes through better data

Sponsored By Truveta

In this whitepaper, learn how MedTech companies can accelerate R&D, monitor products post-market, and improve patient outcomes with clean, complete data from 30+ US health systems and access specific device information from more than 150,000 devices.

The Emergence of Lateral Flow Assays in Diagnostics

The Emergence of Lateral Flow Assays in Diagnostics

Sponsored By Sartorius

Hasret Altan-Martin from Sartorius talks about the ongoing emergence of lateral flow assays (LFAs) in diagnostics. Learn why you should choose Unisart®CN membranes and how their superior sensitivity can change the future of LFA’s. Read more now!

Regulatory strategy as a competitive advantage

Regulatory strategy as a competitive advantage

Sponsored By Rimsys

Medtech regulatory teams have traditionally been treated as operational cost centers with limited investment in people, tools, or digital transformation. This ebook explores how stronger regulatory/revenue alignment can power competitive advantages.

Terumo Enables Global Collaboration and Clinical Excellence for Groundbreaking Medtech Research

Terumo Enables Global Collaboration and Clinical Excellence for Groundbreaking Medtech Research

Sponsored By Veeva Medtech

Terumo, global leader in medical technology, transforms to a unified, digital approach to manage global clinical trials and operations. Read this article to learn about the approach, processes, infrastructure changes, and impact on the business.

2023 MedTech Regulatory Performance Report

2023 MedTech Regulatory Performance Report

Sponsored By Rimsys

See insights and process benchmarks for medtech regulatory affairs from a new survey of 200 regulatory professionals across North America and Europe. The report explores regulatory staffing, workload, compliance issues and costs, and the role of technology and digital transformation.

Johnson and Johnson Standardizes Global Quality on ETQ Reliance

Johnson and Johnson Standardizes Global Quality on ETQ Reliance

Sponsored By etq part of Hexagon

The case study features several best practices that are useful to others who are looking for a single quality management platform on which to standardize and harmonized quality processes and outcomes across multiple locations or business units.

Supplier Quality as Competitive Advantage: Perspectives from PwC, Cardinal Health, and Veeva

Supplier Quality as Competitive Advantage: Perspectives from PwC, Cardinal Health, and Veeva

Sponsored By Veeva Medtech

To address today’s supply chain challenges and ensure quality products it’s critical to have a robust quality management system. Download this article featuring PwC and Cardinal Health for insights on building a business case and supporting digital transformation goals.

AI Medical Device Software Under the MDR

AI Medical Device Software Under the MDR

Sponsored By DNV

This paper reviews some key aspects of safety and performance assessments of AI medical device software according to the existing regulation (EU) 2017/745 (MDR) ahead of the upcoming regulatory updates and standards publication. It also provides a review of requirements to be addressed in order to bring an SaMD to market.

Symmetry Surgical Uses ETQ Reliance Out-of-the-Box to Streamline, Enhance Quality

Symmetry Surgical Uses ETQ Reliance Out-of-the-Box to Streamline Enhance Quality

Sponsored By etq part of Hexagon

Symmetry Surgical® is a leading healthcare technology and solutions provider of high-quality surgical instrumentation, a full-line electrosurgery portfolio, and minimally invasive surgical devices. The company needed to adhere to changing FDA and other regulations while simultaneously protecting its brand value.

Predictive Quality for Medical Devices

Predictive Quality for Medical Devices

Sponsored By Critical Manufacturing

Wouldn’t it be great to know and be able to automatically release products when every process stayed within the specified envelope? And to sample or test only as much as a particular process requires, no more or less? Those are the promises of predictive quality. Get to know what executives from Medtronic, B Braun, Jabil and Ultradent have to say about it.

Increase agility and innovation with PLM for medical devices

Increase agility and innovation with PLM for medical devices

Sponsored By Siemens

Siemens PLM for medical devices is an integrated end-to-end product development system that tackles complexity and regulation through re-use, content capture and collaboration.

The Impact of Covid-19 on the Medical Device Supply Chain

The Impact of Covid-19 on the Medical Device Supply Chain

Sponsored By Loftware, Inc.

It’s no secret, the medical device supply chain was significantly impacted by the COVID-19 pandemic. Discover how leading medical device manufacturing companies adapted to meet the changing demands with labeling to ensure uptime.

Drive Healthcare Transformation with Enterprise-Level Infrastructure

Drive Healthcare Transformation with Enterprise-Level Infrastructure

Sponsored By Arrow and Dell Technologies

Learn the key considerations and best-fit solutions for healthcare transformation that optimize operations for providers and ensure better outcomes for patients. Discover how the Arrow Electronics and Dell Technologies OEM Solutions portfolio can match any healthcare need.

Adapting to COVID-19 with simulation in the medical device industry

Adapting to COVID-19 with simulation in the medical device industry

Sponsored By Siemens

Learn how medical device manufacturers are using simulation to enhance their design process to help fight COVID-19 and continuously innovate.

Preparing for Europe’s New Medical Device Regulation: The Essential Guide to EU MDR Compliance

Preparing for Europe’s New Medical Device Regulation: The Essential Guide to EU MDR Compliance

Sponsored By PTC Arena

Download our whitepaper today as we provide the key steps to making a successful MDR transition, as well as some insights on how an enterprise quality management system (eQMS) solution can help simplify compliance.

6 Requirements for Medical Device Manufacturers in 2022

6 Requirements for Medical Device Manufacturers in 2022

Sponsored By Rootstock Cloud ERP

Discover the 6 key requirements to consider when executing your digital transformation strategy and learn how to turn uncertainty and disruption into a model for sustainable growth.

Data Curation: Enabling your Digital Strategy with a Comprehensive Data Strategy

Data Curation: Enabling your Digital Strategy with a Comprehensive Data Strategy

Sponsored By Innovaccer

With the changing market landscape, heightened patient expectations, pricing pressures, and healthcare reforms, life sciences companies need to quickly adapt to enable high-quality care by embracing digital transformation. Through this whitepaper look under the hood to see how Innovaccer can help life-science companies address these challenges and move towards the digital disease management ecosystem.

7 Principles of Product-Centric Quality Management: A Guide for Medical Device Innovators

7 Principles of Product-Centric Quality Management: A Guide for Medical Device Innovators

Sponsored By PTC Arena

Read this eBook to learn how to overcome process delays, compliance risks, and barriers that impede innovation.

Launching your medical device: A strategy & execution cross-functional guide

Launching your medical device: A strategy & execution cross-functional guide

Sponsored By Definitive Healthcare

Learn how the experts launch their medical devices. Definitive Healthcare’s eBook cowritten by Carl Zeiss Meditec Inc. is packed with checklists and descriptions of all major pre-launch action items each team in your org needs to complete to successfully launch your device.

Unified Medical Imaging Solutions: The Next Evolution in Imaging

Unified Medical Imaging Solutions: The Next Evolution in Imaging

Sponsored By Arrow and Dell Technologies

Move from disconnected PACS and VNA instances to a unified architecture that enables data analysis in real-time and seamlessly shares data with all the stakeholders. Learn about the Arrow Electronics and Dell Technologies OEM Solutions portfolio for unified medical imaging solutions.

The Rise of Implantable Devices

The Rise of Implantable Devices

Sponsored By AMETEK-COINING

In this whitepaper, we'll take a closer look into the state of the medical device industry, in general, and the rise of implantable devices, specifically. We'll touch on how those devices are changing people's lives for the better and what to consider when choosing the right materials that go into making these devices.

Medical device design control with Siemens Digital Industries Software

Medical device design control with Siemens Digital Industries Software

Sponsored By Siemens

The goal of this paper is to dive into the nuanced topics of a requirements management and tracking solution. We will explore the broader use of our PLM tool for concept management throughout their lifecycle.

The Post-Market Gambit: After EU MDR and IVDR: A Systematic Compliance Framework for Driving MedTech Innovation

The Post-Market Gambit: After EU MDR and IVDR: A Systematic Compliance Framework for Driving MedTech Innovation

Sponsored By Huma.AI

Based on extensive research and expert interviews, this 60-page ebook explores the challenges, costs, and opportunities that EU MDR and IVDR have created. Moreover, it offers a solution and vision for a New Era of Post-Market Intelligence.

Upcoming Events & Webinars

September 23, 2026 – 11:00 am – 12:00 pm
Managing Cybersecurity Across the MedTech Lifecycle




Featured Articles

August 19, 2026

Devices are Getting Smarter, Making Materiovigilance Evolve Faster

By Dr. Padmalakshmi Jnaneshwar

According to Deloitte, only 22% of life sciences leaders say they have successfully scaled AI, and just 9% report achieving significant returns. For materiovigilance, this highlights the growing gap between execution and team expectations. Within this gap, fragmented data and manual processes continue to slow response times and increase compliance risk, creating a disconnect between the promise of real-time safety monitoring and operational reality. How can organizations close this execution gap and evolve materiovigilance from a reactive compliance function into a proactive, data-driven discipline?

August 18, 2026

FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices

GenAI-enabled medical devices hold transformative promise for patient care and the broader health ecosystem. At the same time, these devices may introduce unique risks when compared to traditional software and AI-enabled medical devices.  

August 10, 2026
Balancing Cyber Risk

What 524B and QMSR Change About Medical Device Risk

What 524B and QMSR actually require, in plain terms, including the post-market obligation that does not end at clearance? How both map to four kinds of exposure: cybersecurity, product liability, recall, and management liability. Where device makers are commonly unprepared against the new baseline, including the gap between cyber risk and product liability for software and devices.

August 10, 2026

Taking Lean Manufacturing to the Next Level

By Matt Stekier

The increased digitalization of medical device manufacturing makes lean practices more applicable than ever. Keep these factors in mind to put them into action.

August 10, 2026

Why Few MedTech Sales Teams Are Using AI Where It Matters Most

By Lee Smith

A MedTech survey revealed that most sales teams are not using AI for strategic purposes, such as identifying opportunities, prioritizing accounts, or research. Instead, AI is mostly deployed to complete administrative tasks, such as drafting emails and summarizing meetings. Why is more needed?

August 9, 2026
post market surveillance

Why Organizations Miss Emerging Product Risk: Understanding the engineering mechanisms that remain hidden long before complaint trends become visible

By Aalap Patel, MS, CQE, CSSBB

Emerging medical-device risks are often missed because early warning signs are fragmented across complaints, manufacturing, suppliers, returned products, clinical observations, and other data sources; not immediately as statistically significant trends. An engineering-centered, cross-functional approach connecting these weak signals to underlying mechanisms sooner, can improve designs, verification, manufacturing controls, and risk management before isolated issues become widespread quality problems.

August 6, 2026

The Interface is the Risk: A MedTech Blueprint for AI and System Integration

By Aneesh Deshpande

Catastrophic failures rarely stem from isolated hardware bugs. They breed where hardware, firmware, wireless telemetry, and clinical workflows intersect. These silent data integrity failures can invalidate entire research efforts without real-time detection, squeezing V&V Engineers between exploding complexity and compressed timelines.

August 3, 2026
SaMD Readiness

Beyond the Status Report: Using LLMs to Reveal the True State of SaMD Development

By Shreya Sridhar

Medical device software development teams have always struggled with a deceptively simple question: How much of the system is actually complete?

View More Combination Products Articles »

TOPICS

  • Digital Health
  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory

Upcoming Events & Webinars

September 23, 2026 – 11:00 am – 12:00 pm
Managing Cybersecurity Across the MedTech Lifecycle

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Boost Product Quality with Integrated ALM and PLM
Whether you’re managing complex product portfolios, navigating regulatory pressures, or striving to deliver higher customer satisfaction, this guide will help you understand the tangible benefits of integrating ALM and PLM.

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