QS Experts AG provides regulatory compliance and quality management services for medical devices. Services include acting as a Swiss Authorized Representative (CH-REP) and Swiss Authorized Importer (CH-IMPORTER), assistance with Swiss Free Sales Certificates (FSC), MDR/IVDR regulatory consulting, warehousing, administration and accounting, and product registration with Swissmedic.
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Industry:Technical Consulting & EngineeringMedical Technology Industry
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Swiss authorized representative for medical devices and IVDs; review of conformity documentation, labeling, packaging and IFU, Swissmedic registration, complaint handling and authority cooperation.
CH-IMPORTER (Swiss Authorized Importer)
Swiss authorized importer for medical devices; verification of conformity documentation, labeling and UDI, storage and transport requirements, Swissmedic registration, incident reporting and regulatory cooperation.
Free Sales Certificate (FSC)
Application for a Swiss Free Sales Certificate; document review for MDR or IVDR compliance and submission of the FSC application to Swissmedic.
Warehouse – Administrative – Accounting
Warehousing of medical devices, order processing, customer communication, quality assurance, data management, bookkeeping, VAT accounting, accounts receivable and payable, financial planning and tax advice.
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