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Raj Z
@rajzaveri
Medical Device QARA consultant
India
English
About me
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
Skills
Raj Z
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Medical Device Regulatory
I will prepare your ai samd fda 510k submission and regulatory strategy
Medical Device Regulatory
I will create a quality management system for you per iso 13485 and fda qsr 820
4 Reviews
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