Quality Systems
191 articles
Magnetic Beads, Latex Particles, and Gold Nanoparticle Controls for IVD Assays
Guide to qualifying magnetic beads, latex particles, and gold nanoparticles for IVD assays, covering particle specs, conjugation, lot bridging, supplier controls, and regulatory expectations.
Medical-Grade Resin Change Control and Dual Sourcing Guide
Manage resin material changes, supplier notifications, biocompatibility review, revalidation, regulatory filing strategy, and dual sourcing under FDA, ISO 13485, EU MDR, and ISO 10993.
Off-the-Shelf Single-Use Components Qualification for Medical Devices: A Practical Guide
Qualify catalog single-use medical device components under ISO 13485, FDA QMSR, and EU MDR with supplier evaluation, inspection evidence, and change control.
Oligonucleotide, Primer, and Probe Supplier Qualification for IVD Molecular Diagnostics
Qualify oligonucleotide, primer, and probe suppliers for molecular IVD kits with purity specs, lot testing, contamination control, bridging, change notices, and FDA/IVDR expectations.
PCB and EMS Supplier Controls for Active Medical Devices
Qualify PCB fabricators and EMS providers for active medical devices with ISO 13485 controls, traceability, quality agreements, inspection, and monitoring.
Preventive Maintenance and Calibration Intervals for Medical Devices
How to justify preventive maintenance and calibration intervals using risk-based methods, AEM programs, reliability data, ISO 13485, FDA QMSR, and Joint Commission expectations.
Process Validation Ownership at a CMO/CDMO: Who Writes, Who Runs, Who Approves
Assign process validation ownership between OEMs and CMOs/CDMOs, covering protocol authorship, IQ/OQ/PQ execution, approvals, and ISO 13485, FDA QMSR, and GHTF accountability.
Sample Pad, Conjugate Pad, and Absorbent Pad Qualification for Lateral Flow IVD Products
Guide to qualifying sample, conjugate, and absorbent pads for lateral flow IVD assays, including material selection, pretreatment chemistry, lot testing, specifications, and QMS controls.
Sensor and Transducer Supplier Qualification for Medical Devices
Guide to qualifying sensor and transducer suppliers for medical devices, covering supplier criticality, calibration checks, incoming inspection, lot bridging, quality agreements, and monitoring.
Spare Parts Obsolescence Control for Medical Devices: Qualification & Compliance
Guide to medical device spare parts obsolescence, covering last-time buys, alternate part qualification, change control, 510(k) triggers, EU MDR duties, and ISO 13485/QMSR compliance.
Sterilization Supplier Strategy for Medical Devices: Capacity and Dual Sourcing
Manage sterilization supplier capacity risk with EtO and cobalt-60 exposure, dual-source qualification, alternative modalities, quality agreements, and ISO 13485/QMSR planning.
Tubing and Extrusion Supplier Qualification for Medical Devices: From Audit to Validation
Qualify medical tubing and extrusion suppliers, from selection and audits to IQ/OQ/PQ validation, traceability, cleanroom controls, and ongoing monitoring.
MedTech Europe MDR/IVDR 2.0 Position Paper: Proposed Changes
Analyze MedTech Europe's May 2026 MDR/IVDR position paper, including breakthrough and orphan pathways, cybersecurity, AI, IVDR concerns, and the legislative process.
FDA One-Day AI Inspection Pilot: How Elsa Is Reshaping Medical Device Facility Oversight
Guide to FDA's May 2026 one-day AI inspection pilot using Elsa, including facility selection, screening inspection expectations, differences from standard inspections, and readiness steps.
EU AI Act and MDR Single Evidence Matrix for AI Medical Devices
Guide to building one evidence matrix for AI medical devices under EU MDR and the EU AI Act, mapping Annex II/III files, ISO 14971 risks, PMS/PMCF, cybersecurity, data governance, and QMS evidence.
FDA Cybersecurity Unresolved Anomalies Table for Premarket Submissions
Guide to building an FDA unresolved software anomalies table for cybersecurity submissions, including CVSS, exploitability, clinical impact, controls, SBOM links, VEX status, and labeling.
FDA Third Party Review Program: 510(k) Due Diligence Checklist
Evaluate whether 3P510k review fits your device, with checks for product code eligibility, Accredited Person conflicts, eSTAR fit, timing, and risk.
GB PMSR/PSUR Dual Reporting for EU and UK Medical Devices
Structure PMSR and PSUR reports for devices sold in the EU and Great Britain, covering data periods, MHRA format, GB content, FSCA links, and retention.
Home-Use IVD Invalid Result Workflow for Consumer Diagnostics
Design and monitor invalid-result workflows for home-use IVDs, including invalid rates, lay-user errors, repeat testing, IFU comprehension, support scripts, and postmarket trending.
MDR Article 88 Trend Reporting: Statistical Thresholds and Workflow
How to set MDR Article 88 trend reporting thresholds, choose denominators, test significance, escalate severity, link CAPA, and align PMSR/PSUR outputs.