Quality Systems
241 articles
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.
MDCG 2021-5 Rev.1 EU REP Symbol Transition Guide
A regulatory guide to the MDCG 2021-5 Rev.1 EU REP symbol transition, mapping OJEU decisions, Swiss and UK representative rules, and QMS timelines.
Bolivia AGEMED Medical Device Registry Teardown: Weekly Decision Signals
A quantitative analysis of Bolivia's AGEMED weekly registration bulletins: 5,714 decision signals, the high 44% deficiency rate, and importer fragmentation.
Guatemala MSPAS Medical Device Registry Teardown: Database Analysis
A quantitative teardown of Guatemala's MSPAS active-inscriptions list: 26,763 active medtech registrations, IVD-reagent dominance, and the 2026 renewal cohort.
Turkey TİTCK ÜTS Medical Device Registry Teardown: Database Analysis
A quantitative teardown of Turkey's TİTCK ÜTS national medical device register: 5.78M records, domestic-vs-import split, risk-class distribution, and the 1-in-5 rejection rate.
Kazakhstan Medical Device Registry Teardown: NDDA Database Analysis
A quantitative teardown of Kazakhstan's NDDA State Register: 32,117 total registrations (14,048 active), EAEU risk class split, and clinical areas.
Paraguay Medical Device Registry Teardown: DINAVISA Database Analysis
A quantitative analysis of Paraguay's DINAVISA medical device registro sanitario database: 8,162 registrations, product-type split, and leading holders.
Medical Device Cybersecurity Compared: FDA §524B vs EU MDR/MDCG/CRA
A comprehensive regulatory comparison of medical device cybersecurity requirements under US FDA Section 524B and the EU MDR, MDCG 2019-16, and Cyber Resilience Act (CRA).
FDA Insulin Pump Recalls: Medtronic, Insulet, and Tandem — A MAUDE and Class I Teardown
A comprehensive regulatory and clinical engineering teardown of FDA insulin pump recalls. Analyze manufacturer volumes, mechanical root causes, and MAUDE safety trends.
Philips CPAP Recall: PE-PUR Foam, 15 Million Devices, 561 Deaths Teardown
A detailed regulatory and quality system teardown of the Philips Respironics CPAP recall. Understand PE-PUR foam chemistry, the FDA consent decree, and MDR metrics.
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.