This presentation consist of what ISO 14971 is and why is it important to consider this standard while designing a medical device or any device for that matter. It will help u understand what Risk actual is and importance of risk management in medical device industry. It gives you insight about Risk management technique. You will Understand FMEA and how to use it.

1. ISO 14971
This document specifies terminology,
principles and a process for risk
management of medical devices, including
software as a medical device and in vitro
diagnostic medical devices. The process
described in this document intends to assist
manufacturers of medical devices to
identify the hazards associated with the
medical device, to estimate and evaluate
the associated risks, to control these risks,
and to monitor the effectiveness of the
controls

2. Risk Management and RMF
The intent behind Risk Management is to identify, evaluate,
analyze, assess, and mitigate potential product issues.
The process itself includes:
• Risk Management Planning
• Risk Analysis
• Risk Evaluation
• Risk Controls
• Overall Residual Risk Acceptability
• Risk Management Review
• Production & Post-Production Information

3. Risk Management
• Risk :- Combination of the probability of occurrence of harm or severity
of that harm.
• Considering the complexity of medical device design, focused risk
management practices help ensure usability, safety, and regulatory
compliance. It is a process of identifying, controlling and preventing
the failure that may cause hazards to user

4. FMEA

5. FMEA Table

6. Severity

7. Occurrence

8. Detection

9. RPN Number

10. FMEA Table with control methods
and actions
FMEA example

11. Other Major ISO Standards
 IEC 60601-1 : Regulations for Electrical and Electronic medical devices.
 ISO 14001 : Environmentsl Management
 ISO/IEC 27001 : Buisness continiutity
 ISO 45001 : Information security.
 ISO 22000 : Food safety.
 ISO 9001 : Quality mangement[similar to ISO 13485]
 ISO 20000-1 : Service Management.
 ISO 55001 : Asset management.
 ISO 10002 : Customer satisfaction and complience handling
 CE marking for European market.

12. Thank you !