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@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 “healthtech”
2 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
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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