Can this skill help with regulatory authority inspections?

Yes, it includes frameworks for inspection readiness, authority communication strategies, and tracking tools to manage interactions with Notified Bodies and the FDA.

How does it assist with management reviews?

It provides automated scripts and templates for collecting quality performance data, generating real-time KPI dashboards, and structuring reporting for C-level executive reviews.

Is this skill useful for developers in HealthTech?

Absolutely. It helps developers integrate design quality and document control oversight into the software development lifecycle, ensuring that technical output meets strict regulatory requirements.

Does it include tools for tracking quality costs?

Yes, the skill includes tools and guides for analyzing prevention, appraisal, and failure costs to optimize the return on quality investments.

What standards does this QMR skill support?

This skill specifically supports ISO 13485 for quality management systems, EU MDR 2017/745 for European medical device regulations, and FDA 21 CFR 820 for US quality system regulations.

Senior Quality Manager (QMR)

Name: Senior Quality Manager (QMR)
Author: BbgnsurfTech

byBbgnsurfTech

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생산성 및 워크플로

Provides comprehensive quality system governance and regulatory compliance oversight for HealthTech and MedTech organizations.

소개

The Senior Quality Manager Responsible Person (QMR) skill equips Claude with the specialized expertise required to navigate the complex regulatory landscapes of HealthTech and MedTech. It focuses on ISO 13485, EU MDR 2017/745, and FDA 21 CFR 820 standards, offering frameworks for quality governance, management responsibility, and strategic planning. This skill is ideal for organizations needing to maintain high-level compliance oversight, automate management reviews, monitor quality KPIs, and foster a robust organizational quality culture while ensuring audit readiness across multiple jurisdictions.

주요 기능

Multi-jurisdictional compliance tracking for EU MDR and FDA QSR
Automated management review preparation and quality KPI dashboarding
Comprehensive audit program oversight and authority relationship management
ISO 13485 quality system governance and accountability frameworks
3 GitHub stars
Strategic quality planning and cross-functional integration tools

사용 사례

Preparing for Notified Body audits or FDA inspections with structured compliance gap analysis
Implementing a standardized quality culture and leadership development program across R&D and manufacturing
Automating the generation of quarterly management review reports for senior leadership

소개

주요 기능

Multi-jurisdictional compliance tracking for EU MDR and FDA QSR
Automated management review preparation and quality KPI dashboarding
Comprehensive audit program oversight and authority relationship management
ISO 13485 quality system governance and accountability frameworks
3 GitHub stars
Strategic quality planning and cross-functional integration tools

사용 사례

Preparing for Notified Body audits or FDA inspections with structured compliance gap analysis
Implementing a standardized quality culture and leadership development program across R&D and manufacturing
Automating the generation of quarterly management review reports for senior leadership