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134 articles
FDA Patient Preference Information for Medical Devices: 2026 Final Guidance
Guide to FDA Patient Preference Information for medical devices under the 2026 final guidance, including collection methods, validation, regulatory submissions, benefit-risk use, and EU alignment.
SaMD Clinical Evaluation: Clinical Evidence for FDA and EU MDR Submissions
Guide to SaMD clinical evaluation, covering valid clinical association, analytical validation, clinical performance, FDA expectations, EU MDR evidence, and real-world data.
Adhesive Bonding Process Validation for Medical Devices: From Variables to IQ/OQ/PQ
How to validate adhesive bonding for medical devices, including ISO 13485 and FDA QMSR requirements, UV and epoxy variables, IQ/OQ/PQ protocols, surface controls, and revalidation triggers.
Antibody Clone Lock and Lot-to-Lot Bridging for Immunoassay IVD Kits
How to lock antibody clones, manage lot-to-lot bridging studies, and maintain immunoassay IVD performance across manufacturing campaigns under FDA QMSR, ISO 13485, and EU IVDR.
Battery Cell Sourcing for Portable Medical Devices: Supplier Qualification
How to qualify battery suppliers and design medical device battery packs, covering chemistry selection, IEC 62133-2, UN 38.3, BMS controls, traceability, quality agreements, and dual sourcing.
Biological Specimen Sourcing for IVD Development: Serum, Plasma, Matrix
How to source serum, plasma, urine, CSF, and matrix materials for IVD calibrators and controls, covering donor qualification, viral testing, traceability, lot consistency, and regulatory expectations.
Calibrators and Controls Traceability for IVD Kits
How to establish traceability for IVD calibrators and controls, covering ISO 17511 hierarchy models, reference materials, commutability, uncertainty, value assignment, and regulatory expectations.
CDMO Quality Agreement RACI for Sub-Tier Supplier Control
How to structure RACI matrices in CDMO quality agreements for sub-tier supplier control, defining OEM, CDMO, and supplier accountability under ISO 13485, FDA QMSR, and EU MDR.
Coatings and Surface Treatment Supplier Controls for Medical Devices
How to qualify coating and surface treatment suppliers, covering audits, IQ/OQ/PQ validation, specifications, biocompatibility, quality agreements, and monitoring.
Contract Cleanroom Assembly Qualification for Medical Devices
How to qualify contract cleanroom assembly vendors, covering cleanroom classification, environmental monitoring, gowning qualification, quality agreements, audits, and ongoing controls.
Contract Packaging Vendor Qualification for Medical Devices
How to qualify contract packaging vendors, covering ISO 11607 capability, sterile barrier systems, seal validation, labeling, sterilization coordination, quality agreements, and oversight.
Depot Repair QMS for Reusable Medical Device Capital Equipment
How to build a depot repair QMS for reusable capital equipment, covering intake, decontamination, testing, rework, calibration, nonconformance, release, and ISO 13485 records.
Enzyme Supplier Qualification for PCR and RT-qPCR IVD Kits
Guide to qualifying PCR and RT-qPCR enzyme suppliers for IVD kits, covering Taq polymerase, reverse transcriptase, lot bridging, acceptance specs, stability, change control, and FDA/IVDR expectations.
Field Service Traceability for Software-Enabled Medical Devices
Build field service traceability for software-enabled devices with service records, software logs, audit trails, complaint links, QMSR, ISO 13485, and Part 11.
W.L. Gore Acquires Conformal Medical: LAAO Market Analysis
Analysis of W.L. Gore's Conformal Medical acquisition, CLAAS AcuForm LAAO technology, structural heart competition, pivotal trial status, and market impact.
IVD CDMO Tech Transfer Readiness Package: Complete Guide for Diagnostic Manufacturers
Prepare an IVD CDMO tech transfer readiness package with manufacturing specs, analytical method transfer, quality agreements, validation roles, and FDA, ISO 13485, and IVDR expectations.
Legacy Medical Device Transfer to a CDMO: DMR, Validation, and Regulatory Strategy
How to transfer legacy medical device manufacturing to a CDMO while managing DMR handoff, tacit knowledge, change control, process revalidation, and regulatory continuity.
Lyophilized Reagent Fill-Finish and Stability Strategy for IVD Kits
Guide to lyophilized reagent fill-finish for IVD kits, covering formulation, bead and cake formats, humidity control, residual moisture, stability studies, and regulatory documentation.
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.