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FDA
May 3, 2022
FDA

CDRH Releases Update on Actions Related to Philips Respironics 2021 Recall

By MedTech Intelligence Staff

The center is proposing that Philips repair, replace or refund recalled devices manufactured after November 2015.

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Alert
April 27, 2022
Alert

Medtronic Recalls Harmony Delivery Catheter Due to Risk of Capsule Breakage During Use

By MedTech Intelligence Staff

The catheter is part of the company’s transcatheter pulmonary valve system.

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FDA
April 20, 2022
FDA

Risk of False Results with Certain Prenatal Genetic Screening Tests

By MedTech Intelligence Staff

FDA has issued a safety communication to alert patients and healthcare providers about the dangers of inappropriate use of NIPS tests.

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Alert
April 5, 2022
Alert

FDA Issues Urgent Notice to Healthcare Providers Following Endoscope Recall

By MedTech Intelligence Staff

Following Karl Storz’s recall of urological endoscopes, the agency wants to make sure that healthcare providers have seen the company’s urgent labeling update involving sterilization methods.

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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.

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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.

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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.

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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.

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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.

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Columns

October 8, 2026

Cybersecurity by Design: Building Traceable Execution Across the MedTech Lifecycle

How MedTech manufacturers can move cybersecurity upstream, strengthen traceability, and prepare for faster vulnerability response.

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 10, 2026

What 524B and QMSR Change About Medical Device Risk

By Kaleb Averell
Balancing Cyber 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 9, 2026

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
post market surveillance

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.

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 Anthony Watson, Geethapriya (Priya) Setty, Jay Vaishnav, PhD
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.

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

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