Traceability QA & RA Services
Traceability QA & RA Services
4 Follower
Assisting medical device manufacturers with their regulatory obligations. Assistance can be review, advise or hands-on concerning: - Licencing and registrations(CE, 510(k) PMN, HC licence, etc), - Quality Management System development (ISO 13485, US QSR), - R&D and Engineering Management from regulatory perspective.
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