REGULATORY AFFAIRS
MDR & QA
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Medical Device Regulatory Support
We support our customers and distributors at every stage of the product development process. Our regulatory experts have extensive experience in multiple regulatory jurisdictions, including MDR (EU), FDA, CFDA, SFDA, etc.
Go-To-Market Assistance
Regulatory Compliance
Checking the conformity of medical devices
Technical documentation (including ensuring that it is up-to-date)
Post Market Surveillance
Reporting
Certification & Assistance
Our experience is:
FDA 510K / PMA, CE, ANVISA, China FDA, Saudi FDA
UDI Applications
DIN EN ISO 13485 Implementation & Certification
Technical File/Dossier File/Medical Device File
Clinical Evaluation
Medical Device Risk Management
Usability
