Are you planning to enter or currently selling CE-marked medical devices or IVD devices in Europe, either directly or through distributors? Stay in control, avoid distributor conflicts, save time, and ensure compliance by designating GrowthMedics as your independent MDR importer for all European markets.
One Medical Device Importer for 50 countries
With over 30 years of combined expertise, GrowthImports is an ISO13485 service provider aimed to ensure the facilitation of a compliant and smooth international MDR/IVDR compliant importing process in the European market.
Under Article 13 MDR a, importers must meet strict regulatory standards. Ensuring compliance in your supply chain is critical not only for legal repercussions but also to avoid quality issues, commercial and reputation damage.
GrowthMedics, as your dedicated EU MDR / IVDR importer, offers a comprehensive solution to help you meet all EU MDR / IVDR importer requirements while enabling you to focus on scaling your business.
As a market expansion provider, GrowthMedics has successfully established hundreds of distribution partnerships and supported direct sales growth. From sales representation and lead generation to digital healthcare marketing and logistics, we offer a turnkey approach to accelerate your growth.
Article 13 MDR outlines specific obligations for importers of medical devices. GrowthMedics ensures your products meet these requirements by:
Processes exclusively designed and developed to meet ISO13485 and MDR/IVDR article 13 requirements
Verifying product, company, quality documentation and CE certifications
Managing transport and traceability systems to comply with EU regulations
Conducting audits and post-market surveillance activities
By designating GrowthMedics as your EU MDR importer, you can focus on growing your business while we handle the complexities of compliance.
With decades of expertise and having numerous worldwide medical and IVD companies expand into the European market, we offer cost-effective importing services aimed to support your efficiency for sales growth.
Benefit 1: Certificate (ISO13845) icon + “Compliant and seamless MDR/IVDR importing”
With strong regulatory expertise our processes are designed to meet the requirements while minimizing administrative burden and an efficient workflow.
Benefit 2: Passport icon + “One single independent importer for all European and UK markets”
Avoid channel conflicts by designating GrowthMedics as your sole EU MDR importer across all European markets.
Benefit 3: Money and Time icon + “A cost-effective approach to importing”
Minimize time and cost. Pricing of our services are designed to grow with your importing.
Benefit 4: Handshake icon “Your turnkey market expansion partner “
Our expansion services offers support during your growth, from sales representation, fiscal representation, logistics to lead generation and digital healthcare marketing services
By working closely with your team from the beginning, we will ensure alignment and a smooth onboarding process. We will together determine the scope and formalize these in our agreement. Based upon your number of (expected) imports and primary identifier (Basic UDI-DI), we will put together a plan of action and compensation structure.
In a step by step approach we will integrate an efficient importing process for your shipments to the Union.
Customer & Logistics Support: End-to-end support for efficient importing and distribution.
Ensuring a hassle-free importing experience within Europe, we provide a dedicated fiscal representative to help companies own a VAT number, smoothly Import goods, reclaim VAT and comply with the European TAX and VAT guidelines.
If you as a medical device manufacturer have a European entity and you would like to import the goods yourself, we can provide back-office support to keep your operation lean and avoid extra costs and incompliance risks.
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Our regulatory experts are ready to support with any questions you may have.
Tell us how we can help your business succeed in Europe. We have expertise that can help your business to become a top manufacturer in Europe. We will send you an opportunity that can help you grow your business.