Medical Device Risk Management Regulatory Compliance Training - Live Webinars, Recordings & CDs

This risk-based software V&V training will guide you through 11 "must have" elements of software validation and how to use your Risk Management Tools (per ISO 14971:2007).

The presentation will review the complete requirements for Risk Analysis and give an example of how a company can easily create a Risk Analysis in full compliance with the standard. The information will assist in meeting various national and global regulatory requirements for medical devices.

An overview of the new ISO 14971:2007 standard with emphasis on changes from the 2001 version. Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in ISO 14971:2007, a standard recognized by the FDA and rapidly being adopted by industry.

In this Medical device training understand the expectations of FDA and the EU in applying risk analysis to medical devices. Risk Management is required by ISO 13485 and risk analysis by the FDA’s Quality System Regulations (QSR) and by of the EU medical device regulations. Using practical examples, this course look at the regulatory and reporting requirements of EN ISO 14971, "Medical devices - application of risk management to medical devices".

This Internal audit training will guide on how to set up an ISO 14971 audit program with specific auditor guidelines.

This Radiation Sterilization training will review all the changes included in the new standard and how they will affect the device manufacturer.

This Risk Analysis training guide you through the methodologies of and distinctions between Hazard Analyses, dFMEAs, and pFMEAs and step beyond performing Risk Analyses and documenting mitigations to the practical and proactive application. Did you know that you can use your existing Risk Analyses to help you do more than manage risk? Risk Analyses can be used to prioritize and streamline Design Input, Design Output, Design V&V, and both Pre-Production.

This Risk Analysis training will be helped to see how to develop a compliant Hazard Analysis/Risk Management File and Report, as outlined in ISO 14971:2001, a standard recognized by the FDA and rapidly being adopted by industry.