Global

In-depth analysis of Bayer's acquisition of Perfuse Therapeutics for up to $2.45 billion, marking its return to M&A after a 5-year drought. Covers the PER-001 intravitreal implant for glaucoma and diabetic retinopathy, deal structure, endothelin receptor antagonism mechanism, the growing drug-device combination product market, and what it means for ophthalmic medtech manufacturers and investors.

GE HealthCare announced a sweeping restructuring of its business segments and executive leadership team alongside Q1 2026 earnings that missed expectations. Facing $250M in inflationary cost increases driven by memory chips, oil, and freight, the company is raising prices and cutting its profit outlook. Covers the new Advanced Imaging Solutions segment, leadership changes, the inflation impact on medtech supply chains, and what device manufacturers should expect.

Sun Pharmaceutical Industries agreed to acquire Organon & Co. for $11.75 billion in the largest pharmaceutical deal of 2026 and India's largest overseas pharma acquisition. Covers deal structure, Organon's portfolio of women's health products (Nexplanon, NuvaRing) and biosimilars (Hadlima, Renflexis), the drug-device combination products involved, regulatory considerations for combination products, and what the deal means for the women's health and biosimilar device landscape.

In-depth analysis of Danaher's $9.9 billion acquisition of Masimo, the largest medtech deal of 2026. Covers deal structure, strategic rationale, regulatory and antitrust considerations, competitive landscape impact on patient monitoring, and what it means for device manufacturers, hospitals, and investors.

Complete guide to the GLP-1 drug-delivery device landscape in 2026 — auto-injector pens, oral delivery devices, combination product regulatory pathways, FDA and EU MDR requirements, and market outlook.

How Good Clinical Practice applies to medical device clinical trials — navigating ISO 14155:2026 and ICH E6(R3), sponsor and investigator responsibilities, informed consent, safety reporting, and audit readiness.

Complete guide to the RAPS Regulatory Affairs Certification (RAC) in 2026 — RAC-Devices vs RAC-Drugs, eligibility requirements, exam content, 2026 testing windows, study strategies, preparation resources, and how RAC certification advances your regulatory affairs career.

Comprehensive guide to every major medical device trade show and conference in 2026 — including MEDICA, MD&M West, AdvaMed, RAPS Regulatory Convergence, DeviceTalks, and 50+ events worldwide with dates, locations, and what each event delivers.

Complete career guide for medical device regulatory affairs professionals — career paths from entry level to VP, salary ranges by role and region, RAC certification details, essential skills, and how to break into the field in 2026.

Complete guide to ASTM D4169 performance testing for medical device packaging — distribution cycle selection (DC-13, DC-6, DC-12), assurance levels (I, II, III), test schedules (drop, compression, vibration, low pressure, impact), pre-conditioning per ASTM D4332, relationship to ISO 11607 sterile barrier validation, FDA 510(k) requirements, sample size justification, acceptance criteria development, common pitfalls, and step-by-step implementation guide.

How to select a medical device contract manufacturing organization — CMO evaluation criteria, quality agreement requirements under FDA 21 CFR 820 and ISO 13485, audit programs, change control, and step-by-step implementation checklist.

How to design and run decentralized clinical trials for medical devices — FDA final guidance, hybrid vs fully remote models, digital endpoints, wearable data capture, eConsent, and step-by-step implementation framework.

Complete guide to electronic Instructions for Use (eIFU) for medical devices — EU Implementing Regulation 2021/2226 as amended by Regulation 2025/1234 expanding eIFU to all professional-use devices, risk assessment requirements, labeling obligations, EUDAMED UDI integration, FDA electronic IFU policy under 21 CFR Part 801, paper IFU fallback rules, IVDR provisions for IVDs, SaMD-specific guidance, validation expectations, and implementation checklist.

How medical device companies can implement ISO 27001 for information security — ISMS requirements, certification cost and timeline, integration with ISO 13485 and FDA cybersecurity requirements, IEC 62443 comparison, and step-by-step implementation roadmap.

Complete guide to medical device distribution agreements — regulatory clauses, EU MDR Article 14 importer obligations, FDA initial distributor requirements, exclusivity and territory provisions, PMS and vigilance obligations, quality agreements, and negotiation strategies for medtech manufacturers.

Complete guide to medical device registration in the Eurasian Economic Union (EAEU) — national vs EAEU pathway, risk classification (Class I–III), fees, timelines, authorized representative requirements, clinical evaluation, and the 2027/2028 transition deadlines for Russia, Kazakhstan, Belarus, Armenia, and Kyrgyzstan.

How medical device regulatory affairs teams are using generative AI in 2026 — drafting submissions, clinical evaluation, literature review, regulatory intelligence, and quality system compliance. Covers FDA guidance on AI in submissions, GxP requirements, governance frameworks, and practical implementation strategies.

The complete guide to managing Software of Unknown Provenance (SOUP) under IEC 62304 — identification, risk assessment, safety classification, documentation requirements, open-source management, and post-market surveillance strategies.

Complete guide to IoMT (Internet of Medical Things) regulatory requirements — FDA cybersecurity mandates for connected devices, SBOM requirements under Section 524B, EU MDR compliance for IoMT, market size, risk classification, and manufacturer obligations in 2026.

The definitive medical device glossary with 100+ acronyms and terms — FDA pathways (510k, PMA, De Novo), EU MDR concepts, quality systems (ISO 13485, CAPA, DHF), clinical evidence, standards, and international regulatory abbreviations explained.