Webinar on Risk Assessment for Medical Devices

Description :

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 webinar will explore the 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 presented and discussed – Fault Tree Analysis, Failure Mode Effects Analysis, and Failure Mode Effects and Criticality Analysis.

Areas Covered in the Session :

Why Risk / Hazard Analysis is important

Risk Assessment Defined

Regulatory Requirements

Risk Management Process – The Risk Management Plan

Risk Management Documentation

Risk Analysis Processes and Techniques

Asking the Right Questions

The Evaluation / Analysis Tools – FTA, FMEA, and FMECA

Risk Control / Mitigation

Who Will Benefit:

Research & Development

Quality Professionals

Compliance Staff and Officers

Regulatory Affairs

Engineering

Device Design Team

Device Development Team

Consultants