Weekly columnDr Juliane Rossato, PhD
Biomedical scientist with a PhD in clinical and regulatory evaluation of medical devices. More than 15 years in clinical and preclinical research, ANVISA submissions and innovative projects involving stents, TAVI and nanotechnology. Co-inventor of an international patent. Regulatory consultant, university lecturer and FINEP/TECNOVA-RS project leader. Expertise in ISO 14155:2020, MDR 2017/745 and RDC 848/2024.
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ANVISAGood Clinical Practice in Brazil in 2026: What ANVISA's New Reports Reveal About the Future of Medical Devices
The clinical research framework for medicines and the medical device regulatory landscape are converging. Those who understand this first enter the Brazilian market with a real advantage.
QualityQuality of Evidence in Clinical Evaluation: What Regulators Actually Require
Not all clinical data amounts to evidence. Understanding this distinction is what separates an approved dossier from a deficiency request that brings your registration to a halt.