Design Control & Risk Management for Medical Devices

Integrating and Applying ISO 14971 Effectively Within Your Quality System

Pre-Recorded DVD Seminar

Approximately six hours in length on four DVDs, Self Examination and Answer Key Included

Who Will Benefit:

This training solution will benefit medical device professionals in departments such as:

Research and Development, Engineering, QA/QC/RA, Manufacturing/Operations, Legal Affairs, etc.

With Job Functions:

Department managers and supervisors, QA/QC/RA specialists and engineers, Manufacturing, Process and R&D engineers, chemists, scientists, formulators, documentation specialists, auditors, technicians, etc.

Course Description:

With the advent of ISO 14971, both the US FDA and the European Regulatory Authorities have made it clear that Design Controls with an integrated Risk Management Lifecycle must be implemented within your quality system. This course will examine the current industry-regulatory environment and give you tools for survival; it will provide a step-by-step guide to setting-up, operating, and managing Design Controls with an integrated Risk Management System. 

Filmed before a live audience, Michael Barile recognized Design Control, Risk Management and Quality Systems expert, walks you through the essential considerations when integrating and applying ISO 14971 within your product development methodology. 

Learning Objectives 

Participants of this course will learn key concepts essential for the deployment and smooth continuous operation of a Design Control and Risk Management System.  Specifically, they will understand:

  • What the essential elements must be part of your  Design Control methodology.
  • How to perform Design and Development Planning and use it to your advantage.
  • How to structure and painlessly “feed” the Design History File.
  • How to differentiate between “Design Input” and “Design Output”.
  • Why “brain-storming sessions” are NOT Design Reviews.
  • How to generate and execute a Design Master Validation Plan.
  • The essential elements of a verification or validation protocol.
  • Why Risk Management is critical to the effectiveness of your product’s development
  • How to integrate Risk Management into your current Design Control system.
  • What are the Four Steps of Risk Management, the Essential Components of each of these Four Steps and the Risk Management Lifecycle.
  • How to perform and document a Preliminary Hazard Analysis, evaluate identified risks, determine ways to reduce risk and measure this reduction BEFORE finalizing the design
  • When the Risk Management Process should be initiated, risks must be mitigated or controlled and the Risk Management Process ends.
  • How to effectively transfer a new design into production.

Order On-Line to Own This CD Webinar: $795.00 (shipping included)