Design and Development – Design Validation Training
What We'll Cover
Learning Objectives
Learning Objectives
Design Validation Introduction (Part 1)
Design Validation Introduction (Part 2)
Design Validation Introduction (Part 3)
Design Validation Introduction (Part 4)
Design Validation Introduction (Part 5)
Design Validation Introduction (Part 6)
Design Validation Introduction (Part 7)
Chapter 1 - Quiz
Learning Objectives
Design Validation Distinctions (Part 1)
Design Validation Distinctions (Part 2)
Design Validation Distinctions (Part 3)
Design Validation Distinctions (Part 4)
Chapter 2 - Quiz
Learning Objectives
Design Validation Types (Part 1)
Design Validation Types (Part 2)
Design Validation Types (Part 3)
Design Validation Types (Part 4)
Design Validation Types (Part 5)
Design Validation Types (Part 6)
Design Validation Types (Part 7)
Design Validation Types (Part 8)
Design Validation Types (Part 9)
Design Validation Types (Part 10)
Design Validation Types (Part 11)
Design Validation Types (Part 12)
Design Validation Types (Part 13)
Design Validation Types (Part 14)
Design Validation Types (Part 15)
Design Validation Types (Part 16)
Design Validation Types (Part 17)
Design Validation Types (Part 18)
Chapter 3 - Quiz
Learning Objectives
User Needs (UN) Development (Part 1)
User Needs (UN) Development (Part 2)
User Needs (UN) Development (Part 3)
User Needs (UN) Development (Part 4)
User Needs (UN) Development (Part 5)
User Needs (UN) Development (Part 6)
User Needs (UN) Development (Part 7)
User Needs (UN) Development (Part 8)
User Needs (UN) Development (Part 9)
User Needs (UN) Development (Part 10)
User Needs (UN) Development (Part 11)
User Needs (UN) Development (Part 12)
Chapter 4 - Quiz
Exercise 1 : Journey Map
Exercise 2 : User Needs (UN)
Learning Objectives
Design Inputs (DI) (Part 1)
Design Inputs (DI) (Part 2)
Design Inputs (DI) (Part 3)
Design Inputs (DI) (Part 4)
Design Inputs (DI) (Part 5)
Design Inputs (DI) (Part 6)
Design Inputs (DI) (Part 7)
Design Inputs (DI) (Part 8)
Design Inputs (DI) (Part 9)
Design Inputs (DI) (Part 10)
Design Inputs (DI) (Part 11)
Design Inputs (DI) (Part 12)
Design Inputs (DI) (Part 13)
Design Inputs (DI) (Part 14)
Design Inputs (DI) (Part 15)
Design Inputs (DI) (Part 16)
Chapter 5 - Quiz
Exercise 3: Design Inputs
Sample Device - DQS answer review
Our Design Validation course was created by practitioners, for practitioners. Design Validation is crucial to ensure the device User Needs (UN) have been achieved, along with Intended Uses. Poor Design Validation leads to project rework, headaches, and potentially, device recalls or other regulatory actions.
Build a fundamental of Design Validation, and highlight key differences with Design Verification and Process Validation.
Introduce several types of Design Validation, as this key process is not a one-size-fits-all approach, and is best performed in layers.
Focus on finding and authoring well-crafted User Needs (UN), along with the translation process into expertly-written and measurable Design Inputs (DI).
Provide an overview of Risk Management, along with Design Outputs (DO), specifically, the link between the two to identify Essential Design Outputs (EDO).
Knowledge transfer of Design Validation types: Analytical/Bench, Simulated Use, Usability Engineering/Human Factors, Labeling, Software, and Clinical Investigations.
Deep dive into Sample Size Selection to ensure that Design Validations are built on sound engineering judgement.
Loaded with example device exercises, along with activity templates for use in your everyday job.
