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Home
Serivices
Training
Course Offerings
Enrollment Information
Consulting
Areas of Expertise
Why Medgineering?
Submit a Project
Staffing & Recruiting
Staffing & Recruiting Overview
Business Resources
Candidate Resources
About
Partners
Course: Risk Management
Course Objective
Demystify the risk management file. This course includes a review of new ISO 14971:2012 requirements, risk management planning, and alignment of risk management files to DHFs.
Target Audience
All medical device engineers and personnel
Topics of Study (2-3 day course)
ISO 14971: Why?
Risk Management Planning
The Analysis: FMEAs vs. FTAs
Risk Controls
Risk Acceptance
Risk Management Reporting
Residual Risk Management
Request Enrollment information
Courses Available
Quality 101
Innovating with Quality in Mind
Design Controls
Risk Management
Process Controls
CAPA & Non-Conformances
Remediation 101