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Etienne Nichols, Greenlight Guru
March 24, 2022
Etienne Nichols, Greenlight Guru
Soapbox

Three Things You Need to Know About FDA QSR and ISO 13485 Harmonization

By Etienne Nichols

New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.

Continue reading →

Alert
March 22, 2022
Alert

Philips Respironics Recalls Certain Ventilators due to Adhesive Failure

By MedTech Intelligence Staff

Some of the company’s V60 and V60 Plus ventilators were assembled with an expired adhesive, which could cause product failure.

Continue reading →

FDA
March 9, 2022
FDA

FDA’s Final Guidance Pushes Companies to be Recall Ready

By MedTech Intelligence Staff

The agency is urging manufacturers to not only have recall policies in place before a recall is necessary, but to also act quickly in initiating a recall when public health is at risk.

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FDA
February 23, 2022
FDA

Baxter Issues Urgent Safety Notification for Potential Alarm Malfunction in Infusion Pumps

By MedTech Intelligence Staff

Thus far, the company has received 51 reports of serious injury and three reports of patient death over five years.

Continue reading →

FDA
February 8, 2022
FDA

After Two Toddlers Die, FDA Issues Patient Communication for Enteral Feeding Delivery Sets

By MedTech Intelligence Staff

The feeding set tubing can become wrapped around a child’s neck, leading to strangulation or death.

Continue reading →

Joris van der Heijden, StarFish Medical
February 3, 2022
Joris van der Heijden, StarFish Medical
MEDdesign

The Last Major Technical Hurdle for Personalized Medicine:  Manufacturability

By Joris van der Heijden, Ph.D.

Although the future is exciting, it also poses real challenges. More collaborative initiatives need to take place between drug manufacturers and developers of manufacturing equipment and consumables.

Continue reading →

Medtronic
January 25, 2022
Medtronic

Medtronic Recalls Atherectomy System due to Risk of Catheter Breakage

By MedTech Intelligence Staff

The Class I recall affects more than 95,000 devices in the United States.

Continue reading →

Alert
January 18, 2022
Alert

Cybersecurity Attacks Once Again Top ECRI’s Annual Health Technology Hazards List

By MedTech Intelligence Staff

The threat of an attack is imminent. It is critical for medical devices and systems, as well as healthcare facilities to have the right safeguards in place.

Continue reading →

FDA
January 5, 2022
FDA

One Death, Six Complaints: Covidien Recalls Puritan Ventilators Due to Manufacturing Error

By MedTech Intelligence Staff

A capacitor manufacturing assembly error could cause the device to become inoperable.

Continue reading →

magnifying glass
December 2, 2021
magnifying glass

Legal and Normative Requirements: Ensuring the Functional Safety of Medical Devices

EU regulations require manufacturers of medical devices and systems prove the single-fault safety of their products. However, it is not clearly defined in detail how to comply with these requirements. This article explains which technical and legal requirements apply and which aspects should be considered during development.

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Columns

July 7, 2026

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

By Aalap Patel, MS, CQE, CSSBB
post market surveillance

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.

June 29, 2026

Is Your Organization Ready to Govern AI in Regulatory Affairs?

By Geethapriya (Priya) Setty
AI Compliance in Medical Devices

By the time most medtech organizations noticed their teams were using AI in regulatory work, the governance conversation was already running behind.. How can your organization move forward? An Operational AI Capability Maturity Model — a five-domain framework built specifically for regulatory affairs and offers a direct way to assess where your organization actually stands. If your team cannot consistently answer who approved the tool, how the output was verified, and what was retained, this framework is a practical place to start.

April 30, 2026

From Prototype to Production: Building a Validation Strategy That Scales with Manufacturing Volume

By Aniruddha Dhole

Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support future production increases. How does a practical framework for validation, revalidation, and process control help during medical device scale-up?

April 20, 2026

Beyond Reporting: Realizing Continuous Safety Surveillance for Medical Devices

By Jonathan Messer
navigating regulatory strategy

Having already set expectations around the structured capture of medical device safety data, regulators are now ready to analyze related insights, and they expect device manufacturers to match this capability.

March 16, 2026

Chicken or the Egg: Should Device Interoperability or QMS Interoperability Come First?

By Carl Washburn
QMS Interoperability

To achieve medical Device Interoperability, system boundaries need to be defined, system architecture needs to be aligned, and interfaces and communication protocols need to be established across individual components of the medical device. In some cases, it is as important to design and implement QMS Interoperability as it is to design Device Interoperability.

March 13, 2026

The 510(k) Pathway in 2026: Navigating a Shifting Regulatory and Political Landscape for Medical Devices

By Partha Anbil

A persistent tension exists between the drive for rapid technological advancement, the mandate for government oversight, and the paramount importance of patient safety. It is a foundation for the U.S. Food and Drug Administration's (FDA) 510(k) premarket notification process, the primary pathway for new devices to enter the market.

February 23, 2026

Mastering MedTech Intelligence: The Intelligent Product Lifecycle at Fresenius Medical Care

By MedTech Intelligence Staff

Rene Zoelfl, Global Industry Advisor for PTC's MedTech practice, shares how intelligent product lifecycle at Fresenius Medical Care connects cross-discipline teams through a digital fabric built on a shared data foundation.

February 3, 2026

AI in Medical Devices: Safety Questions the Industry Can’t Afford to Ignore

By Pujitha Gourabathini
Safety of AI in Medical Devices

Artificial intelligence is moving quickly into mainstream medical devices, and the industry has become fluent in a familiar set of concerns: bias, transparency, and cybersecurity. These topics matter, but they don’t capture the risks most likely to shape patient safety in the coming decade. The deeper challenges lie in the interactions between algorithms, clinical workflows, data pipelines, and human decision making. Those interactions are where safety is won or lost, and they remain the least examined part of AI adoption.

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  • MedTech Economics
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  • Product Design & Development
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