Medical Devices Regulatory Track Learning Path

The Medical Devices Regulatory Track Learning Path is designed to equip professionals with the comprehensive regulatory, quality, clinical, and post-market knowledge required to bring medical devices and in vitro diagnostics to market and maintain their compliance throughout the product lifecycle. Covering EU MDR 2017/745, EU IVDR 2017/746, ISO 14971:2019 risk management, ISO 13485:2016 quality systems, GCP for medical devices under ISO 14155:2026, FDA 21 CFR Part 820, device safety and vigilance, CAPA management, and regulatory inspection readiness, this programme provides an end-to-end regulatory competency framework for the medical device sector.

Participants will develop an understanding of the EU and US regulatory frameworks for medical devices and IVDs, the quality system requirements that underpin compliant device development and manufacture, risk management obligations under ISO 14971, clinical investigation standards, and the post-market surveillance and vigilance activities required to maintain device approval and patient safety.

How this differs from the Quality & Compliance Professional Learning Path

The Medical Devices Regulatory Track is sector-specific — it focuses on the regulatory frameworks, classification systems, clinical investigation standards, and post-market vigilance requirements that are unique to medical devices and IVDs. It is designed for regulatory affairs specialists, quality professionals, and clinical research teams working specifically within the medical device industry.

In comparison, the Quality & Compliance Professional Learning Path provides a broader pharmaceutical and life sciences quality management education — covering GMP, ISO 9001, deviation management, and validation across pharmaceutical manufacturing and clinical settings. Professionals working at the intersection of device and pharmaceutical regulation may benefit from completing both learning paths.