United States
287 articles
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.
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.
Roche-PathAI Acquisition: AI Digital Pathology and Companion Diagnostics
Analysis of Roche's PathAI acquisition, including AI pathology technology, companion diagnostic strategy, SaMD and IVD regulatory issues, and precision oncology impact.
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.
CareDx-Naveris $260M Deal: Liquid Biopsy and Oncology Diagnostics Strategy
Analysis of CareDx's up to $260M Naveris acquisition, NavDx liquid biopsy technology, TTMV DNA biomarker strategy, transplant-to-oncology pivot, and molecular residual disease market impact.
J&J Atraverse Acquisition: Cardiac Ablation Access Technology and EP M&A
Analysis of J&J's April 24, 2026 Atraverse Medical acquisition, covering HOTWIRE transseptal access, RF guidewire technology, Biosense Webster strategy, and the cardiac ablation M&A landscape.