Regulatory Authorities usually ask applicants to submit all technical documentation translated to Spanish.
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Specific Services
Official Documents
Certificate to Foreign Government (CFG), Free Sale Certificate, ISO 13485 Certificate, ISO 14971 Certificate, and EC Certificate.
Technical Documents
IEC certificates, EMC test report, safety test report, biocompatibility test report, clinical evaluation report, sterilization validation report, stability validation report, and more.
Manufacturer Documents
Declaration of Conformity (DoC), Certificate of Analysis (CoA), Instructions for Use (IFU), QC inspection reports, Risk Management Plan, Risk Management File, STEDs, FMEA, and more.