Legal and regulatory bridging between medical device manufacturers and competent authorities
Direct European entity in Skรฆvinge, Denmark. Handling official liaison with Danish Medicines Agency, EUDAMED registration, vigilance reporting, and technical files validation.
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Full MHRA compliance for Great Britain. Enabling smooth market transition with UKCA marking, device registration, and local regulatory liaison.
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Compliant with Swiss MedDO and IvDO legislation. Dedicated communications with Swissmedic and integration with SWISSDAMED notification pathways.
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Physical legal presence in Illinois, USA. Assisting in official FDA establishment registrations, device listings, and 510(k) pathway requirements.
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Authorized local Australian sponsor to register medical devices in the ARTG database and act as primary contact for the Therapeutic Goods Administration.
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Comprehensive NMPA legal representation and product approval management for international medtech entries into mainland China.
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End-to-end consulting for product safety, clinical evaluations, and international market clearance
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Technical Documentation, CER/PER Clinical Evaluations, PMCF plans, and Notified Body audit support.
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QMS design, gap analysis, mock audits, and continuous regulatory compliance for device manufacturers.
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Fulfilling Article 13 MDR requirements, with specialized importer representations into Spain and European ports.
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Free Sales Certificates (FSC), GPSR product safety compliance, and EU Cosmetics Responsible Person services.
Send us your device specifications for a tailored regulatory roadmap
๐ Global Headquarters (Denmark):
Kaj Sommers Vej 6, 3320 Skรฆvinge, Denmark
CVR: 45000524 ย |ย SRN: DK-AR-000043850
๐ฉ๐ฐ Denmark Office: +45 91632811
๐ฎ๐ณ India Office: +91 9061033526, +91 9349208199
๐บ๐ธ USA Office (Illinois): +1(630) 3468914
๐ฆ๐ช Dubai (UAE) Office: +971 526027286