Global
134 articles
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.
GLP-1 Drug Delivery Devices: Combination Product Pathways 2026
Guide to the GLP-1 drug delivery device ecosystem, including auto-injector pens, oral delivery, combination product pathways, FDA, EU MDR, and market outlook.
GCP for Medical Device Clinical Trials: ISO 14155 and ICH E6(R3) in 2026
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.
RAC Certification Guide 2026: RAPS Exam Prep for Regulatory Affairs
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.
Medical Device Trade Shows & Conferences 2026: The Complete Global Calendar
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.
Regulatory Affairs Career Guide for Medical Devices: Paths, Salaries, Skills
Career guide for medical device regulatory affairs, covering role progression, salary ranges, RAC certification, core skills, and entry strategies for 2026.
ASTM D4169 Transportation Validation for Medical Device Packaging
Guide to ASTM D4169 packaging validation, including distribution cycles, assurance levels, drop, compression and vibration tests, ISO 11607 links, sample size, and acceptance criteria.
Medical Device CMO Selection and Quality Agreement Guide
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.
Decentralized Clinical Trials for Medical Devices: FDA and Hybrid Models
How to design decentralized and hybrid clinical trials for medical devices, covering FDA guidance, remote visits, digital endpoints, wearable data, eConsent, and implementation planning.
eIFU for Medical Devices: EU MDR, FDA Rules, QR Codes, and Paper IFUs
Guide to electronic IFU rules for medical devices, covering EU Regulation 2025/1234, FDA 21 CFR Part 801, website access, QR codes, paper fallback, IVDR, SaMD, and validation.
ISO 27001 for Medical Device Companies: Information Security Implementation Guide
Learn how medical device companies can implement ISO 27001, align ISMS controls with ISO 13485 and FDA cybersecurity expectations, and plan certification.
Medical Device Distribution Agreements: Regulatory Clause Guide
Draft distribution agreements with EU MDR importer duties, FDA distributor controls, territory and exclusivity terms, PMS, vigilance, quality, and negotiation clauses.
EAEU Medical Device Registration: Russia, Kazakhstan, Belarus, Armenia, Kyrgyzstan
Guide to EAEU medical device registration, comparing national and union pathways, classification, fees, representatives, clinical evidence, and 2027/2028 transition deadlines.
Generative AI in Medical Device Regulatory Operations
Use generative AI in device regulatory work with governance for submissions, literature review, intelligence, clinical evaluation, GxP controls, and compliance risks.
SOUP IEC 62304 Compliance Guide for Medical Device Manufacturers
Guide to managing SOUP under IEC 62304, covering identification, risk assessment, safety classification, documentation, open-source controls, and post-market monitoring.
Internet of Medical Things (IoMT): Regulatory and Cybersecurity Guide
Guide to IoMT regulatory compliance for connected medical devices, covering FDA cybersecurity, SBOM expectations, EU MDR obligations, risk classification, and market access.
Medical Device Acronyms & Glossary: 100+ Essential Terms Every Professional Must Know
Medical device glossary with 100+ FDA, EU MDR, quality system, clinical evidence, standards, cybersecurity, and regulatory acronyms explained for professionals.
Engineering Change Order (ECO) for Medical Devices: Complete Process Guide
Medical device ECO guide covering ECR-to-ECN workflows, ISO 13485 design change controls, FDA QMSR expectations, risk assessment, regulatory triggers, and approvals.
Equipment Calibration Management for Medical Devices: ISO 13485 Clause 7.6 Complete Guide
Guide to medical device equipment calibration management under ISO 13485 Clause 7.6 and FDA QMSR, covering traceability, schedules, out-of-tolerance handling, records, and software tools.
Quality Culture in Medical Devices: Leadership Practices Under FDA QMSR
Build medical device quality culture with leadership practices, ISO 13485 management responsibility, behavioral indicators, audits, and FDA QMSR expectations.