Developing the Risk Management File 2017 is a webinar that covers topics such as:
- 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
Developing the Risk Management File 2017 is intended for 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