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Practical Risk Management: How to Integrate ISO 14971 into your Product Development Lifecycle
Medical device risk management using ISO 14971 has become an industry best practice for medical device manufacturers. Adopting ISO 14971 methodology may become burdensome or complex if elements such as risk planning, risk analysis, risk reporting, and postmarket risk surveillance are implemented poorly.

This practical course will highlight key deliverables and how to generate them, reference warning letters and 483s for examples of what and what not to do, and identify when and how to integrate risk management with the typical medical device product development lifecycle.

Learn from David Amor, an industry consultant who specializes in helping companies such as Boston Scientific, St. Jude Medical, and smaller startups navigate through FDA remediation activities surrounding risk management.

Day 1: ISO14971 - Overview and Product Development Process Integration
Date: April 28, 2015
Time: 11:00 AM PDT | 2:00 PM EDT
Duration: 60-minutes

This class will provide an overview of ISO 14971 and describe how the standard integrates with product development process and design controls at various stages, such as design inputs and design verification. We will also review common observations and findings associated with risk management and cover how to avoid common pitfalls.

Day 2: Spotlight on Risk Analysis (FMEA, FTA)
Date: April 29, 2015
Time: 11:00 AM PDT | 2:00 PM EDT
Duration: 60-minutes

This class will focus on not only creating an FMEA but also how it traces to other risk management documentation and design control activities. We will fill in an example FMEA together and learn what triggers FMEA updates. Three types of FMEAs will be reviewed: use, process, and design, with the most emphasis placed on design. The class will also cover risk analysis topics such as determining severity and occurrence, establishing risk levels, and root cause analysis for risk mitigations, as well as explore decision tree and risk matrix elements.

Day 3: Spotlight on Postmarket Risk
Date: April 30, 2015
Time: 11:00 AM PDT | 2:00 PM EDT
Duration: 60-minutes

Complaint files and poor postmarket surveillance integration with a product’s risk management file remain among the top three findings in FDA warning letters since 2007. Today, we’ll cover the oft forgotten but critically important topic of management and integration of postmarket data into your risk management file. We will also cover risk management file maintenance and ongoing updates, as well as risk reporting and auctioning risk (CAPA, remediation). You will learn how to determine which adverse events pose the greatest risk to the organization and how to filter those events by their risk levels.

David Amor, MSBE, CQA

Managing Partner at MEDgineering

Jamie Hartford

MD+DI, UBM Canon