Medical Device Regulatory Affairs (5144835)

Other

Medical Device Regulatory Affairs

$40/hr Starting at $100

Technical file preparation and review of medical device as per EUMDR 2017/745, gap assessment of QMS documents, QMS documents preparation and review for ISO 13485, 510k dossier preparation and review as per USFDA. Risk management file including FMEA preparation as per ISO 14971, Post market Surviellance of medical device

About

$40/hr Ongoing

Download Resume

Technical file preparation and review of medical device as per EUMDR 2017/745, gap assessment of QMS documents, QMS documents preparation and review for ISO 13485, 510k dossier preparation and review as per USFDA. Risk management file including FMEA preparation as per ISO 14971, Post market Surviellance of medical device

Skills & Expertise

Failure Modes (FMEA)ManagementMedical Device DesignRegulatory AuditsReview WritingRisk Management

Sonali Singh 17