Serrah Namini

Serrah Namini

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Industry:

Medical Devices

Skills:

Medical Devices
Fda
Quality System
Iso 13485
Design Control
Iso 14971
Capa
Medical Device Directive
Ce Marking
Combination Products
Regulatory Affairs
V&V
Biomedical Engineering
21 Cfr Part 11
Hardware Diagnostics
Change Control
Regulatory Submissions
Validation
Gmp
Quality Assurance
Iec 60601
Gxp
Iso
Glp
Fda Gmp
Cross Functional Team Leadership
Complaint Management
Commercialization
Capital Equipment
21 Cfr
Iso 9000
Pma
Product Launch
Quality Auditing
Quality Control
R
Regulatory Requirements
Six Sigma
Technology Transfer
U.s. Food and Drug Administration
Corrective and Preventive Action
Verification and Validation

Languages:

English
Italian

Serrah Namini

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Location:

Orange County, California Area

Industry:

Medical Devices