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ALM | Product Realization ISO 13485 Module 7 (Part A)
Module 1
Introduction
Course Introduction
Course Objectives
CFR, ICH and The FDA
Challenges Facing the Medical Device Industry
ISO 13485 Licenses
Module 7 - Product Realization | Part A
Planning
Customer Related Processes
Design and Development - Planning
Design and Planning - General
Design and Development - General Common Mistakes
Design and Development - General Document Approve
Design and Development - Planning
Design and Development - Inputs
Design Inputs
Design and Development - Three Categories of Design Inputs
Design and Development - Inputs (Adequate time)
Design and Development - Outputs
Design and Development - Outputs vs. Inputs
Design and Development - Review
Design and Development Review - General
Collections of Reviews
Design and Development - Review (Systematic Process)
Design and Development - Verification & Validation
Verification
Validation
Validation (MVP)
Design & Development - Product Transfer
Product Design Transfer (DMR)
Control of Design and Development Changes
Document and Change Control
Change Request Details
Change Levels
Design and Development Files - DHF
Design and Development - Product History
Assessment
Final Assessment
Collections of Reviews
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