Insights for Medical Device Professionals

Here's what's happening right now: There were 10,384 new regulatory signals today, including 10,360 FDA Adverse Event Reports (MAUDE/MDRs) and 22 Health Canada mdl entries. Notably, Health Canada issued 2 new recalls: Auro-Canagliflozin for incorrect DIN labeling and LUXA-D for a foreign product in a capsule, both flagged for product safety. For your management review under QMSR and 21 CFR 820, this data isn't just noise—it's critical for quantifying risk exposure and benchmarking against compe

Here's what's happening right now: 10,384 new regulatory signals hit the system today. That includes 10,360 new FDA adverse event reports (MAUDE/MDRs) and 2 new Health Canada recalls. One recall involves incorrect DIN labeling on a blister card (Auro-Canagliflozin), and another involves a foreign product in a capsule batch (LUXA-D). For your CAPA prioritization and complaint handling, notice the pattern in the MDRs: multiple reports for infusion set tubing detachment events and software/app mal

Here's what's happening right now: 2 new Health Canada recalls were issued this week, both for product safety issues. Auro-Canagliflozin has affected lots with incorrect DIN labeling on blister cards, and LUXA-D has a capsule containing a foreign product in the batch. This adds to 10,360 new FDA Adverse Event Reports (MAUDE/MDRs) and 22 new Health Canada mdl signals today, totaling 10,384 new regulatory signals. For RA Managers focused on audit preparedness and post-market surveillance, these s

By TrueMedDevice Team · Apr 01, 2026 · 5 min read | Today's 10,384 signals reveal that software-related malfunctions and supply chain quality issues are the primary drivers of post-market risk, demanding immediate cross-functional action to build audit-ready evidence.

If you manufacture electrosurgical instruments or any device with welded metal components from external suppliers, this recall creates a specific question: could the same supplier validation gap exist in your supply chain?

If you manufacture electrosurgical instruments or any device with welded metal components from external suppliers, this recall creates a specific question: could the same supplier validation gap exist in your supply chain?

Here's what's happening right now: As of March 29, 2026, there are 26,202 new regulatory signals in the market. This includes 26,000 new FDA Adverse Event Reports (MAUDE/MDRs) and 202 new Health Canada mdl entries. These numbers represent the raw volume of post-market activity you need to contextualize for risk assessment and compliance reporting. For a VP Quality/Regulatory, this data isn't just noise—it's critical for quantifying risk exposure and informing your board. The surge in adverse ev

Here's what's happening right now: 26,202 new regulatory signals hit the system today. Among the high-priority FDA Adverse Event Reports, we see multiple malfunctions in insulin pumps (Tandem Diabetes Care's t:slim X2 with Control-IQ Technology) and video systems (Shirakawa Olympus's Visera Video System Center and Camera Head). The Olympus investigation specifically noted "a root cause could not be identified" with the most probable cause traced to "component failure." For CAPA prioritization u

Here's what's happening right now: Today alone, we tracked 26,202 new regulatory signals, including 26,000 new FDA Adverse Event Reports (MAUDE/MDRs) and 202 new Health Canada mdl entries. This volume underscores the critical need for robust post-market surveillance systems that align with updated QMSR and ISO 13485:2016 frameworks. For RA Managers focused on audit preparedness and QMSR compliance, this data signals a heightened focus on documentation and risk management. The surge in adverse e

By TrueMedDevice Team · Mar 29, 2026 · 5 min read | Today's 26,202 signals reveal systemic quality control breakdowns in third-party servicing and persistent software-related malfunctions in connected devices.

Here's what's happening right now: 35 new FDA enforcement actions were issued this week. Among them, a recall for the Penner Pacific Bathing Spa due to missing UDI labeling, and multiple recalls for the Raz Mobile Shower Commode Chair series stemming from a vendor modification that led to improper installation of seat brackets. These signals highlight immediate supplier and labeling risks. For Operations Managers focused on 21 CFR 820.50 supplier controls, this data underscores a critical patte

Here's what's happening right now: 35 new FDA enforcement actions were published this week. Among them, a critical pattern emerges: 5 distinct models of Raz Mobile Shower Commode Chairs (Z300, Z333, Z360, Z200, Z100) were recalled due to a vendor modification causing improper seat bracket engagement. Simultaneously, GEM Premier 5000 systems face Process Control Solution Not Detected errors in their PAK cartridges, with two separate recalls (Part No. 00055415008 and 00055360004) highlighting the

Here's what's happening right now: 35 new FDA enforcement actions were issued today. While the specific device categories aren't detailed in today's signal, this volume indicates active regulatory scrutiny across the medical device landscape. For design engineers, this means your predicate device selection process just got more complex. A recall on your chosen predicate directly impacts your 510(k) substantial equivalence argument and requires immediate updates to your design history file under

Pulse oximeters are among the most widely used medical monitoring devices, yet they are associated with multiple regulatory events. This article analyzes the regulatory landscape including 510(k) clearances, recall trends, MAUDE data, and what RAQA teams should monitor.

A Jira board is not a DHF. Email threads are not design reviews. Learn the 10-step design control workflow, QMSR changes, and how to build a Design History File that survives FDA inspection.

Three CAPAs. Same root cause. No trending analysis. Major nonconformity. Learn why CAPA trending is mandatory, what auditors look for, and the 10-step workflow that prevents repeat findings.

Here's what's happening right now: 391 new FDA recalls were issued this week, with a significant cluster in convenience kits used for dialysis maintenance. Specific examples include Medline's ADD A CATH DIALYSIS KIT (SKU ECVC8415A) and Centurion's CENTRAL LINE INSERTION TRAY (SKU DT19810), where silicone seal failures in Tego Connectors are causing occluded fluid paths and therapy delays. Health Canada added 5 more recalls, including labeling issues with Sterile Contro-Vac suction catheters. Fo