GaMEP ISO 14971 Medical Device Risk Management Training at ATDC

We hope to see you at the next ATDC sponsored HealthTech event on Thursday, November 6 where The GaMEP Medical Device Team will host a 2-hour introductory training session on ISO 14971:2019, the international standard for risk management of medical devices.

This session will be tailored for early-stage and scaling companies. This session will provide a high-level overview of how to identify, assess, control, and monitor risks throughout the medical device product lifecycle. Ideal for startups and growing teams, this training offers foundational insight into integrating risk management into product development strategies to support safety, compliance, and successful market entry. 

Participants will learn about the risk management process, key terms and definitions, and how ISO 14971 aligns with FDA expectations and ISO 13485 requirements. The session will also cover how to build and maintain a risk management file, with practical examples relevant to design, development, and post-market activities.

Click here to register