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1 plugin
@alirezarezvani
Ra Qm Team
14 regulatory affairs & quality management skills for HealthTech/MedTech: ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, GDPR/DSGVO, ISO 27001 ISMS, CAPA management, risk management, clinical evaluation, SOC 2 compliance.
10 skills · plugin

Results for “quality-management”

6 skills
alirezarezvani
Quality Manager Qmr
Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2 for HealthTech and MedTech companies.
20.4k · bundle
k-dense-ai
Iso 13485 Certification
Prepare ISO 13485:2016 certification documentation for medical device Quality Management Systems, including gap analysis, template-based document creation, and compliance checklists.
30.2k · bundle
alirezarezvani
Qms Audit Expert
Provides ISO 13485 internal audit methodology for medical device quality management systems, covering audit planning, execution, nonconformity classification, and external audit preparation.
20.4k · bundle
More results
wondelai
Software Design Philosophy
Manage software complexity through deep modules, information hiding, and strategic programming, with a scoring framework for evaluating design quality.
1.6k · bundle
github
Suggest Awesome Github Copilot Instructions
Suggests relevant GitHub Copilot instruction files from the awesome-copilot repository based on current repository context and chat history, avoiding duplicates with existing instructions and identifying outdated ones.
36.2k
alirezarezvani
Ra Qm Skills
Routes compliance requests to the appropriate regulatory and quality-management skill among 15 bundled options, covering ISO 13485, EU MDR, FDA submissions, ISO 14971, CAPA, document control, ISO 27001, ISO 42001, EU AI Act, GDPR, SOC 2, and auditing.
20.4k