Manufacturing
65 articles
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.
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.
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.
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.
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.
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.