BA mdr-745-specialist
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Use for Annex VIII classification, GSPR, clinical evaluation, EUDAMED, and UDI.
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance.
As a process A 85/100 · Runs to the end — weak spots: execution cost, progress reporting
How to improve
- The SKILL.md body is over 5,000 tokens: move reference detail into references/ and load it when needed.
- 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: 5. Evidence is masked. Grey chips explain why severity was lowered.
Against the Agent Skills spec
- warning
body-longSKILL.md body ≈ 8032 tokens (recommended < 5000); move details to references/ - note
edit-residuethe text marks something as outdated (lines 339, 553): check that old rules are not kept next to new ones — the full check reads the text for contradictions
Process rating: all ten parameters 85/100
- 0Progress reporting. Says nothing while it works
- 40Execution cost. Instruction body is 8032 tokens: crowds the task out of the window
- 50When it triggers. No condition that starts the skill
- 70Inputs and preconditions. Inputs and preconditions are listed
- 100Tools and files. No external tools needed
- 100Steps. 154 steps
- 100Result and completion. Output format and completion criterion are stated
- 100Failures and branches. 1 branches, has a failure section
- 100Consistency. Name and required fields are in place
- 100Running it twice. Mutating operations check current state
- low 22 top-level sections: this looks like several domains in one skill
- low The response is described with custom markup (3 tags): a typed call is more reliable
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)
- +2Single-language instructions
- +3Description length 226: enough signal without eating the budget
- +4Structure: 63 headings
- +3Step-by-step instructions: 154 items
- +3Output format is stated explicitly
- +4Has examples (4 code blocks)
- +4Reference files are cited in the instructions (3 of 3)
- +3All 1 scripts are documented
- +1License stated
Quality base 70; lint remarks subtract, signals add up to 100. Result: 85.