Week 7 : Medical Device Design and Development and Product Realization Process [clutch moment]

Question 1

What is the design control process?

Answer 1

1- Design and development planning
2- Design input
3- Design output
4- Design review
5- Design verification (DVE)
6- Design validation

Question 2

Describe “Design and development planning”

Answer 2

• Describe the design development activities
• Allocate individual responsibility for each activity.
• Review, update and approve the plan
• Until the device design is completed, verified, and validated.

Question 3

Describe “Design input”

Answer 3

• To have a design so that the device’s purpose and the intended use are clear
• Use performance, safety, business economics,
• Risk management
• Regulatory requirements

Question 4

Describe “design output”

Answer 4

• Design output procedures
• include the tests and procedures
• to show conformance with the defined design inputs

Question 5

How are “Design review done”

Answer 5

• Systematically, Planned and arranged

- Documented

Question 6

Purpose of “Design Review”

Answer 6

• evaluate the ability of the results of design and development to meet requirements
• identify and propose necessary actions.

Question 7

Participants at Review Meetings of “Design Review”

Answer 7

• All Functional Personnel

* Specialist personnel

Question 8

Documented Records of “Design Review”

Answer 8

• Records of the results of the reviews
• Any necessary actions shall be maintained
• Identification of the design under review,
• Participants involved
• Date of the review.

Question 9

Describe “Design verificaiton”

Answer 9

•Confirm / Verify that Design Output meets Design Inputs
•Planned and Routine Checks and examined
– Document all Results
– Design verification activities must be planned and routinely examined and the results must be documented in DHF (Design History File)
– Records support the effectiveness of design outputs

Question 10

Describe “design validation”

Answer 10

• Validates the device design
– That the Design Output meets the INTENDED USE
• Use Examination and Objective Evidence – Done through In vitro performance,
– Functional testing
– Anima testing
– Clinical evaluation and trials
•Only done after Successful Design verification
Design verification is done while the design work is being performed,
Design validation then confirms that the MD meets its intended use