Developing the Risk Management File 2017

Topics

• Assignment of Responsibilities and Authorities and a valuable Tool to help Manage them
• The scope of the Plan and its Relationship to the device Life-cycle
• Criteria for risk Acceptability including Distinctions between the International and EU versions
• Review of Risk Management Activities
• The necessary Verification Activities (implementation and effectiveness) and how they can link to the QMS
• Special cases of Risk Acceptability that can often reduce the Risk Management Workload
• Collection, Review, Evaluation, and Action from Production and Post-Production Information Collection

Who should Attend

Medical device manufacturers including:

• R&D Managers
• Top Management
• Project Managers
• Risk Managers
• Design Project Team Members
• Risk Management Team Members
• MDR Specialists
• Complaint Specialists