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About Us
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Turnkey Project Consultants
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FDA 21 CFR Part 820 Quality System Regulation
ISO 13485 – QMS Medical Device
QMS Software (eQMS)
ISO 15378:2017 Certification | Primary Packaging Regulatory Consulting
MDSAP
Product Feasibility & Detail Project Report
Manufacturing Facility
Validation Documentation
Clean Room Guidance
Regulatory Approvals
US FDA 510(k) Consultant
CDSCO Registration
CDSCO Import License
CDSCO Manufacturing License
CE Mark for Medical Device
UKCA Regulatory Consultant
Russia Medical Device Registration
SFDA Approvals
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Drug Device Combination Products
Design History File
US FDA 21 CFR 820.30 Design Controls Requirements
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