Medical device developers face tremendous pressure to bring innovative products to market without delay. As the pace of innovation increases, medical devices incorporating both hardware and software components have become standard, and tech companies are taking note of the market opportunity.

Medical device developers take different approaches to risk management, depending on their product and market conditions. Companies involved in developing medical devices understand the importance of risk management, but their approaches can vary significantly in terms of the time it takes to manage risk, the ability to connect risks to specific requirements and tests, and the capacity to pull together relevant documentation for an audit. To meet these challenges, medical device developers need a comprehensive approach to risk management.

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