Medical Device & IVD Blog
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.
Stryker Acquires Amplitude Vascular Systems: IVL and Peripheral Vascular Strategy
Stryker's May 2026 AVS acquisition adds next-generation IVL for calcified PAD, including the CO2 pressure wave platform, regulatory path, competition, and market impact.
Bayer-Perfuse $2.45B Deal: Ophthalmology Drug-Device Strategy
Analysis of Bayer's up to $2.45B Perfuse Therapeutics acquisition, including the PER-001 intravitreal implant, deal terms, endothelin mechanism, and ophthalmic drug-device convergence.
GE HealthCare Restructuring, Price Hikes, and MedTech Supply Impact
What GE HealthCare's 2026 restructuring, leadership changes, price increases, and $250M inflation hit mean for medtech supply chains and device manufacturers.
Sun Pharma $11.75B Organon Acquisition: Women's Health and Biosimilars
Sun Pharma's $11.75B Organon deal reshapes women's health and biosimilars. Review deal structure, combination-product considerations, portfolio assets, and regulatory impact.
Danaher's $9.9B Masimo Acquisition: Patient Monitoring and Diagnostics Impact
Analysis of Danaher's $9.9B Masimo acquisition, including deal structure, strategic rationale, antitrust considerations, patient monitoring competition, and medtech industry impact.
EU Breakthrough Device (BtX) Designation: MDCG 2025-9 and EMA Pilot Guide
Guide to the EU BtX framework under MDCG 2025-9, covering eligibility, application steps, EMA pilot benefits, FDA comparisons, and IVD implications.
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.
EU AI Act Omnibus Amendment 2026: Medical Device Impact Guide
Explains the May 7, 2026 EU AI Act omnibus deal, product safety exemptions, revised timelines, and compliance actions for AI-enabled SaMD and IVDs.