Quality Systems
191 articles
NMPA Flight Inspections: Preparing for China's Unannounced Audits Under Order 14
A regulatory guide to China NMPA flight inspections under Decree No. 14. Understand unannounced triggers, inspector powers, and GMP readiness for manufacturers.
ISO 14971 Risk-Control Traceability: How to Spot and Fix Audit Gaps
Prepare your Risk Management File for FDA or Notified Body audits. Learn to classify, locate, and remediate risk-control traceability gaps before your next QMS inspection.
Acceptance Sampling Plans for Medical Devices: AQL, Z1.4 & ISO 2859
How to build statistically valid medical device sampling plans under 21 CFR 820.250 / ISO 13485: AQL, ANSI/ASQ Z1.4, ISO 2859-1 switching rules, c=0 plans, and OC curves.
GAMP 5 Computerized System Validation for Medical Devices (2nd Ed.)
A practical guide to GAMP 5 Second Edition for medical device manufacturers: software categories, the V-model, critical thinking, FDA CSA alignment, data integrity, and 21 CFR Part 11.
Medical Device Reliability Testing: HALT, HASS, ALT & MTBF
A practical guide to medical device reliability testing: HALT vs HASS vs accelerated life testing, Weibull and MTBF, Arrhenius acceleration, and where it fits in ISO 13485 design V&V.
FDA 522 Postmarket Surveillance Studies: Section 522 Order Compliance Guide
Understand FDA Section 522 postmarket surveillance orders for Class II and III devices: triggering criteria, the 30-day plan and 15-month start rules, study design, and the public 522 database.
FDA Medical Device Recall Concentration: Top 50 Firms Drive Over Half of All Recalls
Analysis of 58,374 FDA recall records: recall burden is concentrated. The top 50 firms drive 52% of recalls while 42% of firms recalled only once. Zimmer Biomet, Philips, Stryker, and Medtronic lead.
FDA Orthopedic Implant Recalls: Zimmer Biomet Leads 3,167 Hip & Knee Recall Records
FDA recall analysis: 3,167 hip, knee, and shoulder joint-replacement recalls across 70 product codes. Zimmer Biomet holds 37%, the top-10 firms 87%, and 96% are Class II 510(k) devices, not PMA.
Medical Device Economic Operator Duties Compared: EU MDR, NZ, Singapore, Canada, SFDA
Compare sponsor, importer, distributor and authorized-representative duties across EU MDR Articles 11-16, New Zealand WAND, Singapore HPA, Canada MDEL and Saudi SFDA MDS-REQ 9.
QMS/GMP Compared: FDA QMSR, Brazil RDC 665, Mexico NOM-241 & China
Legal-text comparison of medical device quality systems: FDA 21 CFR Part 820 (QMSR), Brazil RDC 665/2022, Mexico NOM-241-SSA1-2025, and China Order 53 — scope, certification, and audit.
FDA Breast Implant Recalls: Allergan, BIA-ALCL, and the 580,000-Report MAUDE Record
Breast implant analysis: 16 Class I FDA recalls (Allergan BIOCELL), 1,380 BIA-ALCL cases, and 580,000 MAUDE reports. Capsular contracture and implant failure lead complications.
FDA Pacemaker and ICD Recalls: 451 Enforcement Actions and the Lead-Failure Record
Pacemaker and ICD analysis: 451 FDA enforcement actions (188 Class I) and 558,000 MAUDE reports. Boston Scientific and Medtronic lead; software and lead-impedance faults dominate Class I.
FDA Surgical Mesh Recalls: 171 Actions and the Polymeric-Mesh MAUDE Record
Surgical mesh analysis: 171 FDA recalls, 15 Class II enforcements, and 145,000 MAUDE reports. Bard/Davol leads recalls and reports; the POP-mesh 510(k) line was pulled to Class III in 2016.
Hemodialysis Recalls: 821 Events Show the Burden Sits in Disposables, Not Machines
FDA hemodialysis recall analysis: 821 events across 26 dialysis codes — 96.6% in disposables and catheters, not machines. 82 Class I actions; Fresenius and Baxter lead.
Home Oxygen Concentrator Recalls: 44 FDA CAW Records and 11 Class I Actions
Home oxygen concentrator CAW recall analysis: 44 FDA recall records; 33 have enforcement classifications, including 11 Class I. Nidek leads the Class I fire record across 52,664 MAUDE reports.
FDA Infusion Pump Recalls: 1,180 Events and the Class I Software-and-Alarm Causes
FDA infusion pump recall analysis: 1,180 events, 189 Class I actions. Software and alarm defects dominate the most serious recalls, led by BD, Baxter, and ICU Medical.
FDA Surgical Stapler Recalls: 19 Class I Actions and the Misfire-and-Fragmentation Record
FDA surgical stapler analysis: 222 enforcement actions, 19 Class I recalls. Ethicon dominates the most-serious actions; malformation, misfire, and fragmentation lead, across 31,000 MAUDE reports.
510(k)-Exempt in 2026: How to Check the QMSR, Registration, and UDI Duties You Owe
A 510(k) exemption removes one filing, not your compliance program. How to confirm exempt status and the QMSR, registration, and UDI duties that survive.
PMA Supplement Types Explained: 180-Day, Panel-Track, Real-Time, 30-Day, and Special
How to choose the right PMA supplement type under 21 CFR 814.39 — 180-day, panel-track, real-time, 30-day notice, and special — with data on what changes actually drive supplements.
FDA QMSR Remediation Mandate: Pre-2026 Findings Now Require ISO 13485
IsoTis and Longhorn warning letters set FDA precedent: pre-QMSR corrective actions must now meet ISO 13485. Internal audit exposure, risk citations, and prep steps.