MDR/IVDR medical device
regulatory importing
services Europe
MDR/IVDR medical device
regulatory importing
services Europe
Place your CE
marked Medical and IVD devices hassle free and compliant with Article 13 EU MDR/IVDR on the European market.
🇪🇺 All EU Countries
🇨🇭 Switzerland
🇬🇧 United Kingdom
Control Over Your Supply Chain
Ship more easily, compliant without conflicts and delays to your distributors.
Ship directly into any EU market while maintaining flexibility to switch or add distributors without disruption.
Controlled processes means we don’t need to physically receive your goods to ensure legal possession and oversight.
Streamlined Processes
Utilize one labeling, onboarding, and tracking process across all EU markets, simplifying medical device import requirements and reducing administrative burdens.
Expanded Market Access
Ship seamlessly to all EU countries, Switzerland, and the UK without the need for multiple importers.
GrowthMedics assumes liability, ensuring compliance with EU MDR importer requirements and smooth operations.
Faster Market Entry
Pre-onboarding with GrowthMedics ensures compliance-ready labels and processes, expediting distributor onboarding.
Conflict-Free Distributor Relations
Prevent conflicts over medical device import licenses and regulatory responsibilities by designating GrowthMedics as a neutral, independent importer.
Reduced Administrative Burden
Simplify your import-export medical devices processes, including labeling, registration, and compliance management, while minimizing costs.
Turnkey importing and market expansion partner
Turnkey exclusive expansion solutions for the medical device industry. Sales representation on the ground, lead and channel development, logistics and warehousing, fiscal representation and digital healthcare marketing services. We offer a turnkey approach to accelerate your growth.
Regulatory EU MDR/IVDR Importer Compliance
Expertise and Compliant with the Importer responsibilities and activities set out in Article 13 of the MDR/IVDR regulations with ISO13485
Onboarding:
Verification of regulatory and technical documentation, certifications, EUDAMED registrations and compliance
Labeling & Registration:
Ensure compliance with MDR/IVDR labeling and registration protocols.
Shipment Tracking:
Digital tracking and monitoring of shipments across the EU, maintaining traceability of the device in the supply chain
Auditing:
Verifying shipments and processes through periodic auditing
Post-Market Surveillance:
Ongoing monitoring and auditing to ensure compliance with EU regulations and report serious incidents or risks to the competent authority
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What sets your service apart from other importers?
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