Complete product V&V including Mechanical, Electrical, Software as per FDA, CE and other required standards.
Clinical testing of medical devices and processes.
Access to all key medical institution in USA and India.
Extensive previous experience conducting medical device trials.
Product Documentation: device design documentation, design history folders, risk analysis documentation, V&V protocols and reports.
Regulatory Submissions and Approvals: Tech Files for CE mark, 510K submissions, TGA submissions, and DCGI submissions.
Full System Builds, Transfer to Production, Volume Production.
Team knows how to make products and systems work.
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