Practical PMS guidance for FDA and Health Canada first — with selected global reference content where useful. Written from the RA/QA perspective.
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.
Engineering finds a field problem. Is it a correction, removal, or recall? Learn the 21 CFR 806 decision tree, health hazard evaluation process, and what happens when you miss the 10-day reporting window.
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.
The most common mistake in medical device risk management: using FMEA Risk Priority Numbers for ISO 14971 risk evaluation. Here is why Detection is not a risk factor, what auditors look for, and what real FDA enforcement data shows.
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
Here's what's happening right now: 391 new FDA recalls were posted this week, with 5 new Health Canada recalls. The dialysis convenience kit category shows multiple signals, including Medline's ADD A CATH DIALYSIS KIT and Centurion's CENTRAL LINE INSERTION TRAY, both citing silicone seal failures that could occlude fluid paths. Meanwhile, Edermy LLC's PIE PAK and PIE Trolley System recalls highlight 510(k) clearance issues, and orthopedic implants from Enovis face labeling errors. For your boar
Here's what's happening right now: 391 new FDA recalls were issued this week, including 5 new signals from Health Canada. Key examples include convenience kits for dialysis maintenance (e.g., Medline ADD A CATH DIALYSIS KIT, Centurion CENTRAL LINE INSERTION TRAY) due to silicone seal issues causing occluded fluid paths, and orthopedic implants like the Reverse Shoulder Prosthesis and EMPOWR 3D KNEE with incorrect labeling. Additionally, there are 26,000 new FDA Adverse Event Reports (MAUDE/MDRs)
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, including specific SKUs like Medline's ADD A CATH DIALYSIS KIT ECVC8415A and Centurion's CENTRAL LINE INSERTION TRAY DT19810. These recalls cite issues like silicone seal failures leading to occluded fluid paths, which could delay therapy or cause leaks. Additionally, there are 26,000 new FDA Adverse Event Reports (MAUDE/MDRs), with notable s
Here's what's happening right now: 391 new FDA recalls were issued this week, including 5 in convenience kits for dialysis maintenance where silicone seal failures could occlude fluid paths. Health Canada added 5 more recalls, with issues ranging from labeling errors to unauthorized devices. In total, today alone brought 26,590 new regulatory signals across FDA and Health Canada databases. For RA Managers focused on audit preparedness and QMSR compliance, this data highlights critical patterns.
By TrueMedDevice Team · Feb 25, 2026 · 5 min read | Today's 1,010 signals expose critical audit risks where high-volume adverse events for active implantables may indicate inadequate trending and cross-jurisdictional alignment in post-market surveillance systems.
By TrueMedDevice Team · Feb 24, 2026 · 5 min read | Today's data reveals a critical pattern: reprocessed single-use devices and software-driven systems are driving enforcement and adverse events, demanding immediate supplier oversight and design control updates.
By TrueMedDevice Team · Feb 20, 2026 · 5 min read | Today's 158 FDA enforcement actions expose critical gaps in supplier qualification, sterile barrier validation, and design verification that cascade into recalls and adverse events.
PMCF (Post-Market Clinical Follow-up) explained at 4 levels — from playground analogy to the MDD-to-MDR evidence crisis. Covers MDCG 2020-7/2020-8 templates, PMCF plan writing, method selection, and why 'not applicable' rarely works with Notified Bodies.
Competitor recall monitoring explained at 4 levels — from playground analogy to strategic intelligence. Covers which databases to monitor, how to evaluate each signal, the regulatory requirement from EU MDR and FDA, and practical solutions for automated monitoring.
The exact questions FDA inspectors, EU Notified Body auditors, and MDSAP auditors ask about your PMS system — explained at 4 levels. Includes the 8 documents to have ready, the 'thread-pull' technique inspectors use, and how pre-inspection intelligence targets your weak spots.
PSUR (Periodic Safety Update Report) explained at 4 levels — from a report card analogy to NB review strategy. Covers MDCG 2022-21 template, section-by-section guidance, common mistakes, and practical tips for RA/QA professionals writing their first PSUR.
Adverse event reporting explained at 4 levels — from simple analogy to multi-jurisdiction filing strategy. Includes the exact reporting timelines for FDA, EU MDR, Health Canada, Japan, Australia, and China, plus the reportability decision tree every RA/QA professional needs.
Post-market surveillance explained at 4 levels — from a 5-year-old's analogy to top researcher analysis. Covers why PMS exists, what RA/QA professionals must do daily, the regulations across FDA/EU/HC, and where the field is heading with RWE and AI signal detection.
How to build a single post-market surveillance system that satisfies FDA, EU MDR, Health Canada, Japan, and other jurisdictions simultaneously. Covers the 8-component architecture, ISO 13485 foundation, MDSAP harmonization, implementation roadmap, ROI analysis, and how automated external monitoring platforms transform RA/QA day-to-day work.
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