Risk Management in Medical Devices Industry

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Risk Management in Medical Devices Industry - US Seminar 2012 at Boston

Website http://www.globalcompliancepanel.com/control/s_product/~product_id=900005 | Edit Freely

Category seminars,Risk Management,Medical Devices Industry,application of risk management,Hazard latency issues,Mitigation strategies and priorities,Critical software issues

Deadline: April 12, 2012 | Date: April 12, 2012-April 13, 2012

Venue/Country: Boston Marriott Long Wharf 8 AM to 5 PM EDT, U.S.A

Updated: 2012-03-14 19:39:49 (GMT+9)

Call For Papers - CFP

Overview: The course will introduce the main elements of risk management and the application of risk management principles and requirements to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management as a mandatory component of almost any activity in the medical device industry.

The course will emphasise the implementation of risk management into the development and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking.

This seminar will address the system level issues of risk management as well as the increasingly important software related issues of critical systems. It will help to comply with regulatory requirements with minimized overhead and resource burden.

Why should you attend: Gaps, incorrect or incomplete implementation can delay or make the certification/approval of products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative.

Course Modules & Content Details:

Day 1, April 12, 2012

Lecture 1:

Risk management planning

Risk management life cycle

Hazard identification

Hazard domains

Hazard latency issues

Risk rating methods

Initial (unmitigated) risk assessment

Q&A Session

Lecture 2:

Mitigation strategies and priorities

Mitigation architectures

Alarm systems as mitigations

Risk control bundles

Post mitigation risk

Residual risk

Safety Integrity levels

Q&A Session

Day 2, April 13, 2012

Lecture 3:

Usability as hazard source and mitigation

Safety requirements

Hazard mitigation traceability

Verification planning

Architectures, redundancy and diversity

Failure mode and effect analysis / FTA

Verification strategies

System validation / mitigation validation

Q&A Session

Lecture 4:

Critical software issues

Software hazard mitigation strategies

Software item, unit and system definition

Software failures as hazard sources

Software requirements and design specification

Software tools and development environment

Software unit and integration testing

Real-time system challenges

Software verification and validation

Mitigation traceability and effectiveness

Q&A Session

Who will benefit:

Project Managers

Regulatory / Compliance Managers and Specialists

Quality Assurance Managers

System Engineering

Hardware Engineers

Software Engineers

Contact Information:

Event Coordinator

Toll free: 800-425-9409

Fax: 302-288-6884

Email: supportglobalcompliancepanel.com

http://www.globalcompliancepanel.com

Price: $1,495.00

GlobalCompliancePanel

1000 N West Street, Suite 1200,

Wilmington, DE 19801, USA

Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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