BC fda-consultant-specialist
Senior FDA consultant and specialist for medical device companies including HIPAA compliance and requirement management. Provides FDA pathway expertise, QSR compliance, cybersecurity guidance, and regulatory submission support. Use for FDA submission planning, QSR compliance assessments, HIPAA evaluations, and FDA regulatory strategy development.
Senior FDA consultant and specialist for medical device companies including HIPAA compliance and requirement management.
As a process C 51/100 · Has gaps — weak spots: result and completion, when it triggers, inputs and preconditions
The same skill appears in 1 more place: RA-Skills
How to improve
- Your own cases (evals/evals.json, 4–6 real requests with expected answers): the full check would then run those instead of a model-drafted suite.
- A spec.yaml with trigger phrases and assertions — a behaviour contract for CI; `skilltest init` writes a template.
Guard findings · 0
✓ No critical or high findings
Files scanned: 4. Evidence is masked. Grey chips explain why severity was lowered.
Against the Agent Skills spec
- note
edit-residuethe text marks something as outdated (lines 60): check that old rules are not kept next to new ones — the full check reads the text for contradictions
Process rating: all ten parameters 51/100
- 0Result and completion. Does not say what the result is
- 0Inputs and preconditions. Does not say what the process needs to start
- 0Failures and branches. Linear process with no failure handling
- 0Progress reporting. Says nothing while it works
- 20When it triggers. No condition that starts the skill
- 30Running it twice. 1 mutating operations with no state check
- 100Tools and files. No external tools needed
- 100Steps. 104 steps
- 100Consistency. Name and required fields are in place
- 100Execution cost. Instruction body is 2614 tokens
Everything here is measured from the skill text rather than judged by a model, so the numbers are checkable. A parameter weighs more when it is a more common reason for the process to stall.
Quality signals
- +5Description has no quoted example phrases that should trigger the skill
- +4Description does not say when NOT to use the skill (false activations)
- +3Output format is not stated: the model decides each time
- -41 reference files, but SKILL.md never points to them: the model will not open them
- -31 of 1 scripts are never mentioned in SKILL.md
- +1No license
- +2Single-language instructions
- +3Description length 348: enough signal without eating the budget
- +4Structure: 20 headings
- +3Step-by-step instructions: 104 items
- +4Has examples (2 code blocks)
Quality base 70; lint remarks subtract, signals add up to 100. Result: 77.