Assess EU MDR 2017/745 Compliance
Medical device teams can miss complex EU MDR obligations across classification, evidence, documentation, and surveillance. This skill structures assessments and explains applicable compliance pathways.
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Review the Skillstore skill "mdr-745-specialist" from https://skillstore.io/skills/davila7-mdr-745-specialist.md and its manifest at https://skillstore.io/api/skills/davila7-mdr-745-specialist/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.
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Using "mdr-745-specialist". Assess likely classification for long-term implantable cardiac monitoring software and list unresolved questions.
Expected outcome:
Using "mdr-745-specialist". Create a gap assessment outline for a Class IIa device transitioning from the Medical Devices Directive.
Expected outcome:
Using "mdr-745-specialist". Outline preparation topics for an initial Notified Body meeting.
Expected outcome:
All 15 static findings are false positives caused by Markdown fences, inline resource names, or ordinary regulatory prose. The reviewed files contain no command execution, network reconnaissance, prompt injection, or other security threat.
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https://skillstore.io/skills/davila7-mdr-745-specialist/audits/9?utm_source=security_passport&utm_medium=share&utm_campaign=versioned_report[](https://skillstore.io/skills/davila7-mdr-745-specialist?utm_source=security_passport_badge)<a href="https://skillstore.io/skills/davila7-mdr-745-specialist?utm_source=security_passport_badge"><img src="https://skillstore.io/badges/skills/davila7-mdr-745-specialist/security.svg" alt="Skillstore security assessment" loading="lazy"></a><iframe src="https://skillstore.io/embed/skills/davila7-mdr-745-specialist.html" title="Skillstore Security Assessment" sandbox="allow-popups allow-popups-to-escape-sandbox" loading="lazy" referrerpolicy="no-referrer" width="420" height="180"></iframe>davila7. (2026). mdr-745-specialist security audit report (audit version 9) [Author version unspecified]. Skillstore. https://skillstore.io/skills/davila7-mdr-745-specialist/audits/9@techreport{davila7-davila7-mdr-745-specialist-2026,
author = {davila7},
title = {mdr-745-specialist security audit report (audit version 9)},
institution = {Skillstore},
year = {2026},
number = {9},
url = {https://skillstore.io/skills/davila7-mdr-745-specialist/audits/9},
note = {Author version unspecified}
}cff-version: 1.2.0
message: "If you use this Skill, cite its author and this versioned security audit report."
title: "mdr-745-specialist security audit report (audit version 9)"
version: "unspecified"
type: report
authors:
- name: "davila7"
date-released: "2026-07-23"
url: "https://skillstore.io/skills/davila7-mdr-745-specialist/audits/9"
identifiers:
- type: other
value: "skillstore:davila7-mdr-745-specialist:audit:9"
description: "Skillstore immutable audit report identifier"
Each author remains a separate installable skill. The recommended variant is ranked by Skillstore evidence.
Why this variant is first
davila7-mdr-745-specialist
2026-09-09
alirezarezvani-mdr-745-specialist
2026-09-09
Compare existing documentation and quality processes with major EU MDR obligations, then organize prioritized remediation work.
Build a structured checklist covering device information, risk management, verification, validation, clinical evidence, and post-market plans.
Identify regulatory readiness questions, evidence gaps, and conformity assessment dependencies before product or company due diligence.
List the main EU MDR topics for a [device type] with intended purpose [purpose]. State assumptions and questions requiring clarification.
Assess the likely MDR classification for [device]. Consider duration, invasiveness, active functions, software roles, and applicable Annex VIII rules.
Compare this documentation inventory with MDR Annex II and III expectations: [inventory]. Return gaps, evidence needed, owners, and recommended priorities.
Create an MDR roadmap for [device and class]. Integrate clinical evidence, QMS, UDI, EUDAMED, Notified Body, PMS, milestones, dependencies, and decision points.
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 · 203 views
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