SinaCrest Healthcare Partners advises medical device and IVD companies on regulatory strategy, market entry, supplier qualification, and cross-border operations. We combine European compliance expertise with on-the-ground execution in China.
EU MDR/IVDR advisory, China NMPA pathway structuring, technical documentation review, and audit readiness programs.
Distributor search, commercial structuring, risk mitigation, and long-term partnership development for European manufacturers.
ISO 13485 verification, on-site factory assessments, QMS evaluation, and OEM due diligence programs.
Supplier monitoring systems, incoming inspection frameworks, and pre-shipment compliance control.
We align regulatory, operational, and commercial considerations into one coherent cross-border strategy.
Local presence in China combined with European regulatory understanding ensures practical, implementable solutions.
Identification and qualification of Class II manufacturer in China leading to CE-compliant private label production.
Full restructuring of technical documentation and remediation of non-conformities after notified body inspection.
For confidential discussions regarding regulatory strategy, supplier qualification, or China market entry:
contact@sinacrest.com