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When are Design Outputs approved?

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After selling the product

Before Design Inputs

After Design Inputs, but before any use in products

When the FDA says to

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Are design and development activities assigned to qualified personnel?

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Yes, all personnel are trained appropriately for specified jobs

No, design and development activities are done by unqualified contractors

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Are design verification records maintained as part of the design history file?

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Yes

No

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How are design specifications translated into production specifications?

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Designated project personnel execute design transfer (with a DMR) to ensure that product design is correctly translated into procedures and specifications

Design transfer occurs automatically

Design specifications are sent to another Department Manager for review and approval

The specifications are copied over with a pen and paper

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Matching: How are responsibilities assigned to each role listed? Drag answers to correct order

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Check Order Of Answers

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Match the text
1. Senior Management
2. Project Leaders & Personnel
3. Quality System Management
4. Department Management

Click and drag
-Ensuring corporate design control procedures are established and maintained -Authorizing and monitoring the progress and compliance of development projects -Assigning adequate resources
-Properly applying design control procedures to their assigned development projects
-Establishing and maintaining all corporate design control procedures as part of the local implementation of the Quality Management System (QMS)
-Ensuring that all personnel are properly trained and design control procedures are being followed

Check Order of Answers

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How often are Management Review Board meetings conducted?

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Monthly

Yearly

Quarterly

Daily

Weekly

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Do design inputs include customer requirements?

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No

Yes

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Do design inputs include applicable requirements for the countries in which you are intending to market?

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No, only appropriate safety and environmental specifications are needed in the design inputs

Yes, design inputs include applicable statutory and regulatory requirements as well as requirements necessary to comply with appropriate safety and environmental specifications.

No, international regulations are all the same

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What do Design Reviews address? Part 1/2

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Comparison of customer needs with technical specifications for materials, products, and processes

Software, marketing strategy, and office set-up

Packaging, handling, storage, and shelf-life requirements

Safety and environmental compatibility

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How long are Design Review records maintained?

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5 years

The life of the product plus 1 year, or 5 years, whichever is longer

They need to be kept forever

The life of the product

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Are design verification records part of the Design History File?

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No

Yes

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What product was the WAVi Headset compared to for the verification and validation study?

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Neuronetrix

Brainscope

Emotiv

Electro-Cap

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What do Design Reviews address? Part 2/2

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Manufacturability of the design, including special process needs, mechanization, automation, assembly, and installation of components

Health care news and patients' results

Safety factors relating to incoming and outgoing items

Product acceptance/rejection criteria

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What do the Design Outputs document?

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Customer complaint records

Evidence that the final design meets input requirements

Acceptance criteria

Characteristics of the design that are crucial to the safe and proper functioning of the product (for example, operating, handling, maintenance, storage, and disposal requirements)

none

All variances during the comparison study require the completion of a Variance Report Form. What does this form NOT contain?

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New Design Plans and Specifications

Impact of Variance on the Study or Equipment Function

Description of Variance

Resolution/Corrective Action