Please answer the following biomedical quality systems questions:

Document controls requires procedures for document:

Question $1$ options:

Preparation

Approval

Distribution

Changes

Question $2(0\mathrm{.}5$ points$)$

The original document approver is required to review and approve any document changes

Question $2$ options:

True

False

Question $3(0\mathrm{.}5$ points$)$

A change to a procedure becomes effective on the approval date.

Question $3$ options:

True

False

Question $4(0\mathrm{.}5$ points$)$

For a device with an expected life of $1$ year, records must be retained for at least how long following distribution

Question $4$ options:

$1$ year

$2$ years

$3$ years

$5$ years

$10$ years

Indefinitely

Question $5(0\mathrm{.}5$ points$)$

For a device with an expected life of $10$ years, records must be retained for at least how long

Question $5$ options:

$1$ year

$2$ years

$3$ years

$5$ years

$10$ years

Indefinitely

Question $6(0\mathrm{.}5$ points$)$

One of the most experienced operators who has been building test devices throughout development has a sheet at his workstation to help him remember the time, temperature, and techniques for creating key device features $.$ Much of this information has been developed over time through trial and error. The operator has shared this knowledge with all fellow operators who will continue manufacturing of the product after Design Transfer. Since all operators already have this information available, it is not necessary to update the production documents.

Question $6$ options:

True

False

Question $7(0\mathrm{.}75$ points$)$

Design review meetings require participation from engineering and quality functions. Representatives from other functions involved in the device design should be included, but are not required by regulation.

Question $7$ options:

True

False

Question $8(0\mathrm{.}5$ points$)$

At a minimum, design review meetings are required annually.

Question $8$ options:

True

False

Question $9(1$ point$)$

Select those statements that accurately reflect the Design Transfer process.

Question $9$ options:

Manufacturing personnel are first introduced to the device

The process during which manufacturing challenges start to be addressed

After completion, device is ready to be marketed

Ensures design is translated into product specifications

Knowledge is transferred from design to production team

Ensures device production is repeatable, reliable, and within process capabilities

Question $10(0\mathrm{.}75$ points$)$

ISO $13485$ requires an approved verification and validation plan listing planned activities to verify and validate the device design.

Question $10$ options:

True

False

Question $11(1$ point$)$

Which of the following may be appropriate for a Design Validation study for an implantable device $($select all that apply$)?$

Question $11$ options:

Patient$/$Clinical study

Animal study

Simulated Use Benchtop Study

Implant Fatigue Benchtop Study

Question $12(1$ point$)$

Production or process changes require

Question $12$ options:

Verification

Validation

Neither

Both

It depends

Question $13(0\mathrm{.}5$ points$)$

Dimensions of a product can be:

Question $13$ options:

Verified

Validated

Either verified or validated

Neither verified nor validated

Question $14(1$ point$)$

Fill in the correct word for Blank $1$ and Blank $2.($Be sure to spell correctly$)$

Question $14$ options:

Blank # $1$

Blank # $2$

Question $15(1$ point$)$

Question $15$ options:

Both the FDA QSR and ISO $13485$ require that a process be

when results cannot be fully

Question $16(0\mathrm{.}5$ points$)$

If destructive testing is necessary to demonstrate a desired result was met then a process should be:

Question $16$ options:

Verified

Validated

Neither

Question $17(0\mathrm{.}5$ points$)$

FDA requires samples from at least $3$ different manufacturing lots to be included when performing process validation.

Question $17$ options:

True

False