SilkVanta
Coordinate evidence without replacing regulated authorities
Selected non-clinical supplies and sourcing support can be assessed case by case. Medical-device classification, quality-system certification, testing, registration and importer duties remain with authorised specialists and economic operators.
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Scope accepted case by case
SilkVanta first confirms product classification, intended use, destination and the specialist authority required. Work is declined when suitable competence or regulatory support is unavailable.
Legal manufacturer and supplier checks
Company identity, operating address and selected capability evidence can be reviewed without treating the supplier as approved for a regulated market.
Quality system evidence
Certificates and quality records can be collected and checked for consistency, while validity and regulatory sufficiency remain with issuing and competent authorities.
Traceability and documentation
Lot identification, material records, labels, instructions and supplied documents are reviewed against the agreed list and current product version.
Inspection scope
Where appropriate, inspection may cover quantity, visible workmanship, dimensions, assembly, pack integrity, labels and buyer-defined non-clinical functions.
Testing and regulatory limits
Sterility, biocompatibility, clinical performance, registration and market authorisation cannot be established through ordinary factory inspection.
Relevant services
Support may include company verification, specialist audit coordination, document collection, restricted inspection scopes and introductions to qualified testing or regulatory providers.