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Upcoming Events & Webinars

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

As medical devices become increasingly connected and software-driven, cybersecurity cannot be treated as a final compliance checkpoint. It must be integrated throughout the entire product lifecycle, from requirements and design to development, regulatory submission, and post-market support. Join experts from PTC and MedCrypt to explore how MedTech manufacturers can embed cybersecurity into product development processes while improving collaboration across engineering, quality, regulatory, and security teams. Attendees will learn how end-to-end traceability and a lifecycle approach can help organizations address evolving FDA and European cybersecurity expectations, reduce risk, and deliver secure, compliant medical devices more efficiently.

Ultimate Posts

IVDR

IVD Intended Purpose: Why it matters more than ever under IVDR

March 21, 2025 6:59 am | By Rich West

Clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers seeking CE Marking and global market access. With IVDR compliance deadlines approaching, how can manufacturers manage risk and avoid regulatory delays and disruptions in their market strategies? Read more →

Upcoming Events & Webinars

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




Featured Articles

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?

July 7, 2026
AI in the EHR

Applying Agentic AI to Healthcare Delivery: The Key to True Transformation

By Jaimon Jose

MTI Viewpoints Insights shared by industry relative to healthcare and...

July 7, 2026
post market surveillance

From Compliance to Clinical Action: Fixing the Broken Loop in Post-Market Surveillance

By Aalap Patel, MS, CQE, CSSBB

Post-market surveillance (PMS) systems in the medical device industry have become increasingly sophisticated in collecting complaints, monitoring adverse events, and generating regulatory reports. However, many organizations still struggle to translate these insights into timely clinical action and meaningful patient safety improvements. This article examines the growing disconnect between regulatory reporting and operational decision-making, explores the challenges of signal detection and prioritization, and outlines practical strategies for building closed-loop PMS systems that improve patient safety outcomes and organizational responsiveness.

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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