Device Risk Management Web-based Seminars

Proper Documentation of Risk Management for Compliance with ISO 14971 - Webinar GlobalCompliancePanel Overview: There are a wide variety of risk management tools cited in ISO 14971, the medical device risk management standard. Tuesday, May 8, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Post-Design Medical Device Risk Management - Webinar GlobalCompliancePanel Overview: In this presentation we will explore the requirements for post-design risk management and determine how to apply the requirements. Tuesday, April 24, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Proper Documentation of Risk Management for Compliance with ISO 14971 - Webinar By GlobalCompliancePanel There are a wide variety of risk management tools cited in ISO 14971, the medical device risk management standard. Tuesday, May 8, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Post-Design Medical Device Risk Management - Webinar By GlobalCompliancePanel In this presentation we will explore the requirements for post-design risk management and determine how to apply the requirements. Tuesday, April 24, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel This webinar will update personnel at medical device companies on the ISO 14971 standard and point them to the additional information available in the document under the informative annexes. The information will assist in meeting various national and global regulatory requirements for medical devices.  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ...ry agencies world wide, with good reason. EU's ISO 14971 (Device Risk Management) and the FDA's QSIT and Q9, underscore this increased emphasis. A valid closed-loop CAPA system requires root cause analysis for true problem (not symptom) resolution. Growing high-profile field problems indicate that effective root cause analysis is still not the industry norm. The billions of dollars spent by  more...

The Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel Overview: The purpose of FMEA is to affect the design and the most practical time to do this is when competing designs are being considered, not after choices have been made, contracts signed, and prototypes being built and tested. Of course, there are other reasons for performing a FMEA. FDA requires risk assessment (hazard analysis) but a FMEA conducted late in the product development process  more...

Developing the Risk Management Plan - Webinar By GlobalCompliancePanel ...ould attend: One of the major requirements of the medical device risk management standard ISO 14971 is to develop a Risk Management Plan. One of the least understood and executed requirements are the Risk Management Plan. As ISO 14971 becomes required for product safety certification and is audited by regulators this requirement will become a greater issue. The Risk Management Plan establishes  more...

Failure Modes and Effects Analysis FMEA - An Effective Tool for Medical Device Risk Management - Compliance Webinar by GlobalCom The presentation will discuss the proper use of FMEA in risk management and how to recognize and avoid the traps associated with this tool in order to have a more efficient risk management process.  more...

Proper Use of Risk Management Tools for ISO 14971 Medical Device Safety - Webinar by GlobalCompliancePanel ... we will use examples of the use of the tools for medical device risk management to complete the risk management process for a sample medical device. During the presentation we will refer to the risk management standard ISO 14971 and its requirements. We will give examples for completing the documentation requirements of the standard. The presentation is intended to give practical information  more...