Medical Devices by their very nature must be safe for human use and must meet the requirements for which they have been designed.  The process which identifies the risks associated with a medical device that could make the device unsafe or not function as intended is called Risk/Hazard Analysis.

21 CFR Section 820 requires that comprehensive risk analysis be performed as part of the medical device regulatory submissions process and throughout the product’s lifecycle.  ISO 14971 is the risk management standard for medical devices. Its purpose is to help manufacturers establish a risk management process that can be used to identify hazards, estimate and evaluate risks, and develop, implement, and monitor the effectiveness of risk control measures.  This three-hour virtual seminar will discuss both the regulatory requirements and the process for conducting effective Risk/Hazard Analysis. 

The secret to preventing medical device recalls or at least to minimizing their impact is sound Risk/Hazard Analysis.  Aside from being required, it is absolutely essential and necessary to the development and fielding of medical devices that offer a significant level of protection for patients and manufacturers alike.  

The session will explore the basic principles of risk management and planning as they relate to medical device design and as required by the FDA.  It will present a logical process for risk management from risk identification through evaluation/rating and mitigation.

The tools and techniques of Risk Analysis and the rating process used to evaluate the risks identified will be introduced – Fault Tree Analysis, Failure Mode Effects Analysis, and Failure Mode Effects and Criticality Analysis. 

Why Should You Attend:

Risk management is critical in medical device design because medical devices are intended to improve the health and quality of life of patients. However, if medical devices are not properly designed and manufactured, they can pose significant risks to patients, including injury, illness, or even death. Therefore, risk management in medical device design is essential to ensure that medical devices are safe and effective for their intended use.

There are several reasons why risk management is important in medical device design:

• Regulatory Requirements: Regulatory agencies such as the FDA require medical device manufacturers to implement a risk management process to identify and mitigate potential hazards and risks associated with their devices. Failure to comply with these requirements can result in regulatory action, including device recalls, fines, and even legal action.

• Patient Safety: Medical devices are used to diagnose, treat, and monitor patients, so it is critical that they are safe and effective. Proper risk management helps to identify potential hazards and risks associated with medical devices and allows for the implementation of appropriate risk control measures to minimize the risk of harm to patients.

• Reputation: The reputation of medical device manufacturers is closely tied to the safety and effectiveness of their devices. Failure to properly manage risks associated with medical device design can result in negative publicity and loss of public trust.

• Cost: Failure to manage risks in medical device design can result in significant financial costs for manufacturers. For example, if a device is found to be unsafe or ineffective, it may need to be recalled, resulting in significant financial losses for the manufacturer.

In summary, risk management is important in medical device design to ensure patient safety, comply with regulatory requirements, protect the reputation of manufacturers, and minimize financial costs associated with design failures.

Course Outline:

I. Introduction

• Overview of medical device design and development process

• Importance of risk management in medical device design

• Brief overview of regulatory requirements related to risk management

II. Risk Management Process

• Steps in the risk management process (ISO 14971)

• Key concepts and definitions (e.g., hazard, harm, risk, risk assessment, risk control, residual risk)

• Overview of risk management tools and techniques (e.g., FMEA, FTA, HACCP, PHA, etc.)

• How to identify and evaluate risks throughout the device lifecycle

• Importance of continuous risk management and updating the risk management file

III. Risk Analysis Techniques

• Hazard identification and analysis techniques

• Estimating the likelihood and severity of harm

• Risk evaluation and prioritization techniques

• How to perform a risk analysis on a medical device design

• How to document the results of the risk analysis

IV. Risk Control Techniques

• Overview of risk control techniques (e.g., elimination, substitution, engineering controls, warnings, etc.)

• Selection and implementation of appropriate risk control measures

• How to document the results of the risk control process

V. Risk Management File and Documentation

• Overview of the risk management file

• Documentation requirements for risk management (e.g., risk management plan, risk analysis report, risk control plan, etc.)

• Importance of documentation in demonstrating compliance with regulatory requirements

• How to maintain the risk management file throughout the device lifecycle

VI. Conclusion and Q&A

• Recap of key takeaways

What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points

Who Will Benefit:

Personnels in Quality, production, compliance, engineering, R & D, management – essentially everyone in the organization that is involved in the design and development of medical devices.