Practical articles on regulatory affairs for biomedical device and pharmaceutical professionals.
Which medical devices count as high-risk AI, what the Digital Omnibus shifted, where MDR/IVDR and the AI Act overlap, and a practical 2026 action plan for SaMD developers.
May 23, 2026What CE marking really guarantees, what it doesn't, and the practical things every clinician, nurse, lab technician and procurement officer should know about medical device safety, the risk class system, and incident reporting.
May 18, 2026Most Clinical Evaluation Report rejections under EU MDR stem from weak scientific evidence, not formatting. What strong evidence looks like, and why scientific expertise — separate from regulatory expertise — changes outcomes.
May 15, 2026How to navigate EU MDR, IVDR, and FDA regulatory pathways for biosensor medical devices. Classification, clinical evidence, and submission strategies for startups.
April 5, 2026Navigate 2026 MDR deadlines with a practical action plan covering EUDAMED mandatory registration, NB capacity, and compliance budgeting.
February 13, 2026Navigate the IVDR transition with practical timelines, Notified Body strategies, LDT requirements, and cost estimates for small laboratories.
February 12, 2026Step-by-step CER writing guide covering data sources, equivalence claims, PMCF integration, and common Notified Body findings.
February 11, 2026Practical guide to building a lean QMS with core SOPs, FDA QMSR alignment, certification costs, and common audit findings.
February 11, 2026Understanding Annex VIII classification rules and how to apply them to your medical device portfolio. Covers all 22 rules with practical examples.
February 10, 2026A breakdown of the 5-module eCTD structure and tips for organizing your regulatory dossier efficiently.
February 8, 2026A side-by-side comparison of the two major regulatory pathways and what they mean for your submission strategy.
February 5, 2026