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Quizzesspmed04-documentation-compliance

SPMED04 Documentation & Compliance

Overview Textbook Workbook Instructor notes Knowledge check

Knowledge check

Documentation & Compliance Reporting

12 questions in pool · live exam draws 5

SPMED04

12 questions · live exam draws 5

Q1 multiple-choice · regulator-view

How do regulators view medical product photographs?

A) As aesthetic / marketing content
B) As evidence supporting specific submission claims (substantial equivalence, labeling correctness, risk control, etc.)
C) Optional supplementary material
D) For brand validation only

Source: SPMED04 §1.

Q2 multiple-choice · substantial-equivalence

What’s the photography role in a 510(k) substantial equivalence claim?

A) Comparison imagery showing new device + predicate device side-by-side; supports substantial equivalence argument
B) Marketing imagery only
C) Not required for 510(k)
D) Cost analysis

Source: SPMED04 §1.

Q3 multiple-choice · package-structure

Right discipline for submission package organisation?

A) Single flat folder
B) Hierarchical directory (primary_views / packaging / labels / IFU / reference / metadata + chain-of-custody)
C) Random naming
D) Email attachments only

Source: SPMED04 §2.

Q4 scenario · reshoot-discipline

RA requests reshoot of label closeup due to illegibility.

A) Replace v1 with new version
B) Keep v1; capture as v2; document reason in reshoot_log; update chain-of-custody; customer approves
C) Capture v2; delete v1
D) Skip versioning

Source: SPMED04 §4.

Explanation: Never delete originals. Version, document, retain. Audit trail integrity.

Q5 multiple-choice · ra-collaboration

Right communication discipline with customer’s RA team?

A) Verbal only
B) Single point of contact + documented requests + joint reviews + iteration loop with documentation
C) Customer’s RA waits for Specialist to deliver
D) Specialist sends final package directly to regulator

Source: SPMED04 §3.

Q6 multiple-choice · rejection-categories

Common rejection reason CATEGORIES (5 main):

A) Aesthetics + cost + speed + branding + style
B) Quality + coverage + compliance + process + package
C) FDA + EMA + ISO + national + competitor
D) RA + QA + Sales + Operations + IT

Source: SPMED04 §5.

Q7 scenario · audit-question

During audit, inspector asks: “Why was this reshoot performed?”

A) “Customer requested it”
B) Reference reshoot log entry: date + reason + requester + customer approval + v1 vs v2 changes
C) “I don’t remember”
D) Refuse to answer without RA present

Source: SPMED04 §6.

Explanation: Have documentation. Reference factual records. Be honest + boundary-respecting.

Q8 true-false · regulatory-interpretation-audit

During audit, Specialist should interpret what the regulator expects + answer regulatory questions.

True
False ← CORRECT

Source: SPMED04 §6.

Explanation: Stay in technical lane. Defer regulatory interpretation to RA. “RA can answer that” is the discipline.

Q9 multiple-choice · revalidation-trigger

Which is NOT a re-validation trigger?

A) Equipment change (new camera, lens, lighting)
B) Process change (SOP update)
C) Personnel change (new operator on critical pipeline role)
D) Customer’s marketing rebrand

Source: SPMED04 §7.

Explanation: Marketing changes don’t affect photography pipeline validation. Equipment / process / personnel changes do.

Q10 multiple-choice · rejection-prevention

Most effective rejection prevention discipline?

A) Specialist self-audits package against rejection-category checklist before delivery to RA
B) Submit and hope
C) Bulk submit; wait for regulator feedback
D) Customer’s RA catches everything

Source: SPMED04 §5.

Explanation: Pre-submission self-audit catches preventable issues. Cheap; catches embarrassing defects.

Q11 scenario · ra-handoff

Submission package ready for delivery to customer’s RA. Last step?

A) Send immediately
B) Joint review with RA + medical writer before formal delivery; iterate any flagged issues; sign off; then delivery
C) Wait for RA to ask
D) Skip review — Specialist’s deliverable is final

Source: SPMED04 §3.

Explanation: Joint review catches issues before formal delivery. Cheap insurance.

Q12 multiple-choice · file-naming

Right file naming convention for medical submission package?

A) Random ID; resolved later
B) Predictable + sortable + no spaces + no special characters; per-language explicit; version explicit
C) Customer’s marketing names
D) Photographer’s preference
Total: 12 questions
Multiple choice: 11
True/False: 1
Drawn per attempt: 5

Source: SPMED04 §2.

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