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andria93 replied to the topic Risk Management in the forum Project Management Process and Medical Device Development 7 years, 3 months ago
As it was mentioned in the lecture of this week, Risk management sometimes takes place after the deployment of the product. As a field application engineer, we write a FAR report based on eight disciplines problem-solving. D5, D6, and D7 which is verification of solution, corrective action, and preventive action. these three points have to be approved by upper management, PM of the product and sales representative. As it could affect the project planning. especially if these products for project qualification and corrective/preventive actions required adjustments for the mass production.