Post-Market Surveillance
72 articles
OEM vs Independent Ultrasound Service Provider: A Due Diligence Decision Tool
A neutral due-diligence framework for HTM and procurement leaders to evaluate OEM vs independent ultrasound service routes across QMS evidence, software licensing, calibration, and acceptance testing.
Ultrasound Board and Probe Repair Quality Agreement: Depot Deliverables and Clause Set
A contract-stage deliverables schedule and clause set for independent ultrasound repair depots, using 21 CFR 820.35(b) fields as a record template where appropriate.
How to Verify an Ultrasound Repair or Parts Provider's ISO 13485 and QMS Claims
A desktop-verification guide to auditing ISO 13485 scope, accreditation status, IAF CertSearch records, and FDA registration claims for ultrasound service vendors.
Teleflex Global Regulatory Dossier: Arrow, UroLift, FDA Data & 2025 Sale
Data-driven regulatory dossier of Teleflex (NYSE: TFX): ~440 FDA 510(k)s, multi-country registration counts, Arrow Class I recalls, and the 2025 $2.03B divestiture.
Aesthetic Medical Device Adverse Events and Recalls: A MAUDE Data Analysis
A data-driven analysis of FDA MAUDE adverse events and recalls across aesthetic device classes, analyzing breast implants, lasers, dermal fillers, and cryolipolysis systems.
Botulinum Toxin Adverse Events: Refreshed FAERS Safety Analysis
A comprehensive teardown of botulinum toxin adverse events in the FDA FAERS database, comparing safety profiles of Botox, Dysport, Xeomin, Jeuveau, and Daxxify.
Continuous Glucose Monitor FDA Recalls & MAUDE: Dexcom & Abbott Teardown
An in-depth analysis of continuous glucose monitor (CGM) recalls and MAUDE safety data, comparing Dexcom and Abbott sensor, receiver, and software failures.
CT, MRI & Fluoroscopy FDA Recalls: Siemens, Philips & GE Teardown
A safety teardown of CT, MRI, and fluoroscopy recalls. We review Siemens, Philips, and GE recall volumes, magnet venting risks, and cybersecurity issues.
FDA Anesthesia Machine Recalls: GE, Dräger & Getinge MAUDE Teardown
A manufacturer-spanning teardown of FDA anesthesia system recalls and MAUDE adverse events, analyzing GE Carestation, Dräger Atlan, and Getinge Flow.
FDA Heart Valve Recalls: Edwards, Medtronic & Abbott MAUDE Teardown
A manufacturer-spanning teardown of FDA heart valve recalls and MAUDE database adverse events, analyzing Class I events and common failure modes.
Managing End-of-Service (EOS) Medical Equipment: Lifecycle Risks & HTM Fleet Controls
A data-driven playbook for managing aging multi-brand ultrasound fleets after receiving an OEM End-of-Service (EOS) letter, detailing safety statistics, tender data, and parts planning.
Ultrasound Board-Level Failure Patterns: An HTM Field Guide to Root-Cause Diagnosis
A comprehensive HTM guide mapping ultrasound console symptoms to board-level failures (PSU, beamformer, motherboard) with FMECA data and repair-vs-replace rules.
Ultrasound Probe Repair vs Replace: An HTM Decision Framework With MAUDE Evidence
A detailed guide for HTM and biomedical engineering teams to evaluate whether to repair or replace diagnostic ultrasound transducers based on failure modes, safety risks, and compliance.
Coronary & Peripheral Stent Recalls: Boston Scientific, Abbott & Medtronic Teardown
A manufacturer-spanning deep dive into FDA stent recalls and MAUDE adverse event reports. Analyzes 131 recalls, common failure modes, and recent 2025-2026 high-acuity events.
ESU Recalls: ConMed, Stryker, Megadyne & Olympus Surgical-Fire and Burn Teardown
A manufacturer-spanning deep dive into FDA electrosurgical unit (ESU) recalls and MAUDE adverse event reports. Analyzes 640 recalls, surgical fire risks, and QMS implications.
External Defibrillator & AED Recalls: ZOLL, Stryker, Philips & Cardiac Science Teardown
A manufacturer-spanning teardown of automated external defibrillator (AED) and external defibrillator recalls and MAUDE events. Analyzes 373 recalls, common failure modes, and QMS implications.
Baxter FDA Device Footprint: 510(k), PMA, Recall & Manufacturing Analysis
A comprehensive data-driven regulatory profile of Baxter's FDA clearances, PMA approvals, safety recalls, and manufacturing hubs after the Hillrom acquisition.
Becton Dickinson (BD) FDA Device Footprint: 510(k), PMA, Recall & Manufacturing Analysis
A comprehensive data-driven regulatory profile of Becton Dickinson's FDA clearances, PMA approvals, safety recalls, and manufacturing hubs after the 2026 Waters spin-off.
FDA Ventilator Recalls: Class I Events, MAUDE Deaths & Root-Cause Analysis (2024–2026)
A data-driven analysis of FDA ventilator recalls, MAUDE database adverse events, root-cause categories, and major Class I events from Vyaire, Hamilton, Baxter, and Philips.
FDA 510(k) Predicate Best Practices: Recall History, Creep, and the 2026 QMSR Gate
A regulatory strategy guide analyzing the FDA's predicate-selection best practices, predicate-creep recall risk, and the 2026 QMSR parallel gate.