r
rajzaveri

Raj Z

@rajzaveri
5.0(4)

Medical Device QARA consultant

India
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Sobre mí
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... Lee más

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r
rajzaveri
Raj Z
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Revisa mis servicios

Reglamentos para dispositivos médicos
I will prepare your ai samd fda 510k submission and regulatory strategy
5.0(4)
Reglamentos para dispositivos médicos
I will create a quality management system for you per iso 13485 and fda qsr 820

4 Reseñas
5.0

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Desglose de calificaciones
  • Nivel de comunicación del Freelancer
    5
  • Calidad de la entrega
    5
  • Valor de la entrega
    5
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