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IN-COUNTRY REPRESENTATIVE
EC REP/EUDAMED listing
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UKRP / MHRA PARD listing
US Agent / FDA listing
Egyptian registration holder
SFDA registration
REGULATORY IMPORTER
EU Regulatory Importer
Swiss Regulatory Importer
UK Regulatory Importer
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UK FSC from United Kingdom
e-CFG from USA
WAREHOUSING SERVICE
Warehouse in EU
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Regulatory
Compliance
EU MDR/ IVDR COMPLIANCE
MDR/IVDR TF preparation
Al and M/L compliance
Subject matter expert review
Clinical investigation
Clinical evaluation
PSUR
PMCF preparation
Biocompatibility
Risk management file
Usability engineering
FDA COMPLIANCE
Establishment registration
PMA Approval
510k Approval
Reduced fees guidance
OTHER DOMAIN COMPLIANCE
Egypt [EDA Application and approvals]
Saudi Arabia [file preparation according to SFDA MDMA 1/2]
Quality
Services
ISO & QMS SERVICES
ISO 13485 implémentation
MDR QMS Article 10 (9) compliance
Software compliance (part 11/ GAMP)
Third party audit support
ISO 13485 certification process
Management Report preparation
PMS reporting
CAPA reporting
Incident Case handling and reporting
PRODUCT DEVELOPMENT
Brand Design
Legal guidance
Design control file preparation
Product development plan
Production Layout Design
Packaging Design
OEM regulatory setup
IFU / E-IFU implementation
Document translations
SWISS PRODUCT BRANDING
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