Two Day Risk Management in Medical Devices Industry Seminar (Cambridge, United States - October 19th-20th, 2017)

Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment.

Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment.

Like any process that tries to produce repeatable and consistent results, the risk management process must be clearly understood, including the strengths but also the limitations.

By attending this seminar you will learn the main elements of ISO 14971, ISO 13485, IEC62304, IEC62366-1/-2, risk management life cycle steps and benefits, and FDA software reviewers' guidance.

Learning Objectives:

Who Should Attend:

Day 01 (8:30 AM - 4:30 PM)

08.30 AM - 09.00 AM: Registration

Lecture 1: Introduction To Risk Management And Quality System Integration

Lecture 2: Risk Management To ISO 14971:2012

Day 02 (8:30 AM - 4:30 PM)

Lecture 3: Software And Usability In Risk Management
Software Risk Management (IEC62304 / FDA Software Reviewers' Guidance)

Lecture 4: Usability And Risk Management (IEC62366-1/-2 / FDA Human Factors Guidance)

Lecture 5: Risk Management Report And Safety Case

For more information about this conference visit https://www.researchandmarkets.com/research/7782w9/risk_management

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Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com

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