Quality Systems
241 articles
Is This Reagent an ASR or a Finished IVD?
Mark whether one US reagent SKU is still an ASR under 21 CFR 864.4020 and 809.30, an RUO or IUO shipment, a general-purpose reagent, or a finished IVD with performance claims.
Which Combination-Product 4.4 Path Still Applies After QMSR?
A practical 21 CFR 4.4 worksheet for combination product facilities after QMSR: how to verify eligibility, separate-facility rules, and current ISO 13485 or drug CGMP streamlining clauses.
Combination Product Safety Reports: Which Clock, Which System, Which Applicant?
A practical 21 CFR Part 4 Subpart B worksheet mapping applicant identity, 4.102 baselines and add-ons, statutory reporting clocks, and electronic routing between FAERS, eMDR, and VAERS.
VetMedGuide: Building a Useful Veterinary Device Field-Feedback Form
A manufacturer intake worksheet for veterinary analyzer complaints: separate instrument observation, species and matrix, clinic QC evidence, and unsupported causality.
NMPA GMP Announcement 107: Dual Release, Key-Person Gates, and the 1 November 2026 Clock
China NMPA GMP Announcement 107 operating guide: Order 53 manufacturing licenses vs 107 GMP, dual release, full-time key-person gates, and 1 November 2026.
EClinCloud EDC for Device Studies: Linking Versions, Deficiencies and Endpoints
Evaluate whether a configurable EDC study build can reconstruct device models, firmware versions, deficiencies, and endpoint records for FDA and EU MDR trials.
HSA GN-21 R7 Change Notification: 6Aii/6Aiii Approval, Two-CN Cap, & August Clock
Singapore HSA GN-21 Revision 7 change notification guide: when 6Aii/6Aiii SMDR updates require approval, the two-active-CN cap, and the 1 August 2026 clock.
FDA 2026 Container Closure Draft: Device-Constituent CCS, 510(k), & October Clock
FDA August 2026 container closure systems draft guidance: device-constituent CCS vs packaging, 510(k)/PMA vs NDA, Section V.B.3, and Docket FDA-2026-D-7957.
Malaysia MDA Automated Re-Registration: MeDC@St 2.0+, July 2026 Switch & CN Trap
Operational guide to Malaysia MDA's Automated Re-Registration Route in MeDC@St 2.0+: six eligibility gates, CN-first sequencing, QMS whitelist, fees, and TAT.
India G.S.R. 743(E): Outsourced Sterilization Labels, 14 Feb 2027 Clock & Ninth Schedule
Guide to CDSCO G.S.R. 743(E) Medical Devices Second Amendment Rules 2026: Rule 44(p) label prefixes, 14 Feb 2027 clock, Ninth Schedule fees, and loan licences.
Health Canada MDEL Phase 2: Foreign Distributor Exemption, Supplier Lists & GUI-0016
Operating guide to Health Canada MDEL Phase 2 (SOR/2026-110, GUI-0016 Dec 14 2026): keep-or-cancel, supplier lists, procedures, and CAD $5,519.
ISO 20417:2026 Guide: FDA Rec# 5-149, July 1 2029 DoC Window & ISO 15223-1
Operational guide to ISO 20417:2026: FDA Rec# 5-149 complete recognition, the July 1 2029 DoC transition window, ISO 15223-1, 21 CFR 801, and EU MDR GSPR 23.
IEC 62353 Recurrent Testing After Repair: OEM IFU Duties vs IEC 60601-1 & NFPA 99
IEC 62353 in-service electrical safety testing: manufacturer IFU duties, IEC 60601-1 type test differences, CMS S&C 14-07 major repair rules, and NFPA 99.
ISO 80369 Small-Bore Connector Conversion: 510(k), FDA Windows & Particular Parts
Manufacturer ISO 80369 conversion guide: route-specific particular parts, FDA recognition transition windows through Dec 17, 2028, and 510(k) change forks.
NSAI NB 0050 Medical Devices Divestment 2026: Stay vs Transfer Playbook
Playbook for NSAI NB 0050 clients on the 2026 divestment: confirmed facts, stay-vs-transfer tree, MDR Article 58, IVDR Article 53, MDSAP.
Medical Device Trial Master File (TMF) and ISF Guide: ISO 14155, FDA, and EU MDR
Complete guide to medical device TMF and ISF: ISO 14155:2026 Annex E essential documents, 21 CFR 812.140, EU MDR archiving, and device-unique artifacts.
Should You Trust AI in Regulatory Work? A Vendor-Neutral Checklist After DJ Fang's Pilot
A vendor-neutral operational audit for medtech RA and quality teams evaluating AI workflow tools, covering CSV, source provenance, master dossier reuse, and reliance.
Disposable Circumcision Device Supplier Qualification: CE, ISO 13485 & MOQ
A purchasing-control guide for qualifying disposable circumcision device suppliers: CE marking, ISO 13485 scope, size mix, MOQ landed cost, and sample acceptance.
Medical Cyanoacrylate Tissue Adhesive Sourcing & Regulatory Guide
A technical sourcing guide for medical cyanoacrylate tissue adhesives: intended use classification, 2-octyl vs n-butyl chemistry, ISO 10993, and lot release.
NPWT Supplier Qualification: Pump–Dressing Compatibility, Alarms, QMS and Total Cost
A technical due-diligence guide for qualifying NPWT systems: pump-dressing compatibility, alarm performance, regulatory scope, and total cost of therapy.