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rajzaveri

Raj Z

@rajzaveri
5,0(4)

Medical Device QARA consultant

India
Engels
Sommige informatie wordt in het Engels weergegeven.
Over mij
Detail-oriented Quality and Regulatory Affairs professional with more than six years of experience in US FDA, CE, TFDA (Thai FDA) and UKCA regulatory submissions for medical devices. Expertise in: 1. Premarket Notification (510(k)) 2. Presubmissions 3. EU regulatory submissions (Technical File and CER) as per the MDR 4. Setting up Quality Management System as per ISO 13485 and CFR 820 5. Establishing a sound Risk Management System as per ISO 14971 6. Creating and implementing SDLC documents as per IEC 62304... Lees meer

Skills

r
rajzaveri
Raj Z
offline • 

Bekijk mijn diensten

Regelgeving voor medische hulpmiddelen
I will prepare your ai samd fda 510k submission and regulatory strategy
5,0(4)
VanafUS$ 1.000 / projectMeer informatie
Regelgeving voor medische hulpmiddelen
I will create a quality management system for you per iso 13485 and fda qsr 820
VanafUS$ 2.000 / projectMeer informatie

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