Working with more than 200 medical device developers, Jama Software has established best practices for risk management in Jama Connect™.
This paper takes you through the main clauses of ISO 14971 — the FDA’s mandatory standard for risk assessment in medical devices — and outlines how Jama Connect gives you a comprehensive way to manage risk and requirements throughout development.Learn how to:
- Understand ISO 14971 and FMEA
- Identify, analyze and mitigate risk
- Connect risks and requirements
- Achieve end-to-end traceability
- Ease the path to compliance