Global

Analysis of Roche's PathAI acquisition, including AI pathology technology, companion diagnostic strategy, SaMD and IVD regulatory issues, and precision oncology impact.

Guide to qualifying sample, conjugate, and absorbent pads for lateral flow IVD assays, including material selection, pretreatment chemistry, lot testing, specifications, and QMS controls.

Guide to qualifying sensor and transducer suppliers for medical devices, covering supplier criticality, calibration checks, incoming inspection, lot bridging, quality agreements, and monitoring.

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.

Manage sterilization supplier capacity risk with EtO and cobalt-60 exposure, dual-source qualification, alternative modalities, quality agreements, and ISO 13485/QMSR planning.

Qualify medical tubing and extrusion suppliers, from selection and audits to IQ/OQ/PQ validation, traceability, cleanroom controls, and ongoing monitoring.

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.

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's May 2026 AVS acquisition adds next-generation IVL for calcified PAD, including the CO2 pressure wave platform, regulatory path, competition, and market impact.

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.

What GE HealthCare's 2026 restructuring, leadership changes, price increases, and $250M inflation hit mean for medtech supply chains and device manufacturers.

Sun Pharma's $11.75B Organon deal reshapes women's health and biosimilars. Review deal structure, combination-product considerations, portfolio assets, and regulatory impact.

Analysis of Danaher's $9.9B Masimo acquisition, including deal structure, strategic rationale, antitrust considerations, patient monitoring competition, and medtech industry impact.

Guide to the GLP-1 drug delivery device ecosystem, including auto-injector pens, oral delivery, combination product pathways, FDA, EU MDR, and market outlook.

Apply Good Clinical Practice to medical device trials under ISO 14155:2026 and ICH E6(R3), with sponsor duties, consent, safety reporting, and audit readiness.

Prepare for the 2026 RAPS RAC exam with guidance on RAC-Devices vs RAC-Drugs, eligibility, exam content, testing windows, study resources, and career impact.

Plan 2026 medical device trade show attendance with dates, locations, and event focus for MEDICA, MD&M West, AdvaMed, RAPS, DeviceTalks, and other global conferences.

Career guide for medical device regulatory affairs, covering role progression, salary ranges, RAC certification, core skills, and entry strategies for 2026.

Guide to ASTM D4169 packaging validation, including distribution cycles, assurance levels, drop, compression and vibration tests, ISO 11607 links, sample size, and acceptance criteria.

How to select a medical device CMO, define quality agreements, run supplier audits, manage change control, and align outsourced manufacturing with FDA QMSR and ISO 13485.