quality-manager-qmr
Strengthen MedTech Quality System Governance
HealthTech teams must coordinate quality governance, regulatory oversight, and management review across complex obligations. This skill provides structured QMR frameworks for planning, monitoring, escalation, and executive reporting.
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Review the Skillstore skill "quality-manager-qmr" from https://skillstore.io/skills/davila7-quality-manager-qmr.md and its manifest at https://skillstore.io/api/skills/davila7-quality-manager-qmr/manifest. Verify the artifact. You may proceed after verification, subject to the environment's own policy.Your Agent should still show its plan and request any confirmation required by the security policy.
Agent-readable resources
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Test it
Using "quality-manager-qmr". Build a quarterly management review agenda for a Class II medical device company.
Expected outcome:
- QMS performance: audits, nonconformities, corrective actions, complaints, and process trends.
- Regulatory status: FDA obligations, ISO 13485 certification, emerging requirements, and inspection readiness.
- Decisions: resource priorities, risk escalations, improvement owners, deadlines, and effectiveness checks.
Using "quality-manager-qmr". Propose quality priorities for a HealthTech company entering the European Union.
Expected outcome:
- Confirm product classification, conformity pathway, and QMS scope.
- Assign ownership for technical documentation, post-market activities, supplier controls, and regulatory monitoring.
- Track readiness through evidence-based milestones, executive reviews, and documented risk escalation.
Using "quality-manager-qmr". Define a concise quality cost dashboard.
Expected outcome:
- Prevention costs: planning, training, supplier development, and risk controls.
- Appraisal costs: inspection, testing, audits, and certification.
- Failure costs: rework, scrap, returns, complaints, recalls, and regulatory actions.
Security Audit
SafeAll 17 static findings are false positives caused by Markdown fences, inline filenames, and ordinary regulatory or quality terminology. The skill contains no shell commands, environment-variable access, network reconnaissance, prompt injection, or malicious intent.
Risk Factors
⚙️ External commands (14)
🔑 Env variables (1)
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APA citation
davila7. (2026). quality-manager-qmr security audit report (audit version 9) [Author version unspecified]. Skillstore. https://skillstore.io/skills/davila7-quality-manager-qmr/audits/9BibTeX citation
@techreport{davila7-davila7-quality-manager-qmr-2026,
author = {davila7},
title = {quality-manager-qmr security audit report (audit version 9)},
institution = {Skillstore},
year = {2026},
number = {9},
url = {https://skillstore.io/skills/davila7-quality-manager-qmr/audits/9},
note = {Author version unspecified}
}CITATION.cff
cff-version: 1.2.0
message: "If you use this Skill, cite its author and this versioned security audit report."
title: "quality-manager-qmr security audit report (audit version 9)"
version: "unspecified"
type: report
authors:
- name: "davila7"
date-released: "2026-07-23"
url: "https://skillstore.io/skills/davila7-quality-manager-qmr/audits/9"
identifiers:
- type: other
value: "skillstore:davila7-quality-manager-qmr:audit:9"
description: "Skillstore immutable audit report identifier"
Compare variants
2 installable variantsEach author remains a separate installable skill. The recommended variant is ranked by Skillstore evidence.
Why this variant is first
alirezarezvani-quality-manager-qmr
2026-08-21
davila7-quality-manager-qmr
2026-08-21
Skillstore Score
Why this score Evidence Confidence: HighWhat You Can Build
Prepare Management Review
Build an agenda covering QMS performance, compliance status, customer feedback, quality costs, resources, decisions, and follow-up.
Plan Multi-Market Compliance
Map oversight priorities across ISO 13485, EU MDR, FDA QSR, and applicable national requirements.
Set Quality Strategy
Align quality objectives, investments, KPIs, culture initiatives, and cross-functional responsibilities with business goals.
Try These Prompts
Create a QMR responsibility matrix for [company type], covering QMS oversight, regulatory compliance, management reporting, and continuous improvement.
Draft a quarterly management review agenda for [company], using these metrics: [metrics]. Include decisions, owners, escalation criteria, and required follow-up.
Assess this QMS summary against ISO 13485, EU MDR, and FDA expectations: [summary]. Identify gaps, priorities, evidence needs, and management actions.
Develop a three-year quality strategy for [company and markets]. Integrate regulatory risk, resources, KPIs, quality costs, culture, audits, and executive governance.
Best Practices
- Provide company size, product type, target markets, current certifications, and known quality risks.
- Validate every recommendation against controlled procedures and current jurisdiction-specific requirements.
- Assign owners, due dates, evidence, escalation thresholds, and effectiveness measures to each action.
Avoid
- Do not treat generated guidance as regulatory approval or legal advice.
- Do not create universal controls without considering product risk, market requirements, and organizational maturity.
- Do not report performance without source data, definitions, owners, and review periods.
Frequently Asked Questions
What does this skill help a QMR produce?
Which regulatory frameworks are covered?
Can it confirm regulatory compliance?
Does it include working dashboards or automation?
What information improves the output?
Can executives use this skill directly?
Developer Details
Author
davila7License
MIT
Skillstore revision
r2
Version notice
The author did not declare a version.
Ref
c43861a65bb95efcae259cd161c9d6f4dc7eec6f
Maintenance freshness
7/24/2026
Usage
10 downloads · 279 views
File structure