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2-day In-person Seminar on “Implementing Risk Management Principles and Activities within a Quality Management System” at Sydney

Risk Management Principles

24 25 February 2014

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Risk management integrated into the overall quality management is one of the main components for global medical device compliance. To meet the approval requirements for almost every regulated market a comprehensive implementation and documentation of a full risk management lifecycle has to be demonstrated. This course introduces the major components necessary to achieve global regulatory compliance and approvability. The main emphasis is on European and US regulation. A practical path to implanting a successful risk management system across different subsystems will be presented. The main issues covered are risk management, compliance with IEC60601-1, usability engineering and software risk management. The course is based on 20+ years of experience in the medical device industry and emphasizes practical implementation issues and not just theoretical background. If your company is developing devices for international markets this seminar will give you the information needed to design and document a globally acceptable design lifecycle.

1 speaker

2 sessions

Day 1 from 9am to 6pm Monday 24th February 2014

Day 2 from 9am to 6pm Tuesday 25th February 2014

2 known attendees

  • GlobalCompliancePanel
  • Markus Weber

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