About MDR Academy

MDR Academy is a leading-edge regulatory intelligence platform specifically engineered to streamline compliance for the medical device industry.

Our Mission

We believe that professional regulatory guidance should be accessible, instantaneous, and high-quality. In an era of increasing regulatory complexity—marked by the transition to MDR (EU) 2017/745 and IVDR (EU) 2017/746—we provide the tools necessary to maintain compliance with confidence.

Core Expertise

• Regulatory Intelligence: Our engine is continuously trained on official sources, MDCG guidances, and harmonized standards.
• AI-Driven Precision: We leverage LLMs to help professionals find answers across thousands of pages of legislative text in seconds.
• Industry Focus: Developed by a team by a team of regulatory experts and software engineers dedicated exclusively to medical device compliance.

Our Vision

To become the primary digital companion for Regulatory Affairs professionals worldwide, accelerating the safe delivery of innovative medical technologies to patients.