Medical Device & IVD Blog
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.
FDA Servicing vs Remanufacturing Decision Tree for Medical Devices
Classify medical device repair, maintenance, software, and modification work under FDA's May 2024 servicing versus remanufacturing guidance.
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.
Medtronic CathWorks and Scientia Deals: Cardiovascular and Neurovascular
Review Medtronic's 2026 CathWorks and Scientia Vascular deals, covering FFRangio coronary diagnostics, neurovascular access technology, deal value, and tuck-in M&A strategy.
Microfluidic Cartridge Materials and Diagnostic Tapes for IVDs
Select microfluidic cartridge materials and diagnostic tapes for IVD devices, covering COC, COP, PMMA, PC, PP, bonding, molding, leachables, supplier qualification, and validation.
Nitrocellulose Membrane Selection for Lateral Flow Assay IVD Performance
Select nitrocellulose membranes for lateral flow IVDs using pore size, capillary flow rate, protein binding, backing, lot qualification, and FDA or IVDR expectations.
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.