Medical and IVD Device (MDR/IVDR) Compliant Importing in Europe | GrowthMedics
Medical and IVD Device (MDR/IVDR) Compliant Importing in Europe | GrowthMedics
Why do you need MDR/IVDR & MHRA Importing Services?
- Documentation & license review
- EU & UK importer representation
- Labeling & product registration
- Shipment verification & tracking
- Post-market surveillance & audit support
Enter the Compliant, Hassle-free and consolidated Importing of your CE marked Medical and IVD Devices in Europe and the UK
GrowthMedics ensures your CE-marked devices meet every MDR/IVDR and MHRA requirement by removing barriers, complexities and help avoid channel conflicts among distributors providing one single importer, one labelling system and process throughout the EU and UK market.
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Step
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What we do
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Results
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Documentation & Import License Review
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Compliance with EU & UK regulatory standards
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Designated Article 13 MDR importer and MHRA
importer
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Shipment Verification & Tracking
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Labeling & Registration
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Ensure MDR/IVDR & MHRA conformity
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Post-Market & Audit Support
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Post-Market & Audit Support Ongoing monitoring and reporting
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Our Regulatory Importing Services will provide:
- Ensure regulatory compliance with MDR/IVDR article 13
- Ensure faster EU and UK market entry for direct sales and
- Virtual importing to avoid shipping delays
- Ship direct to your customers or through Amazon market places
- Continue shipping direct to customers and distributors
- One efficient labelling and registration process
- Ship seamlessly to all EU and UK countries without the need for multiple importers.
- Keep your distributors’ time and resources focused on sales
- Conflict-free and less dependency on distributor relationships
- Reduced Administrative Burden by simplifying processes and minimizing costs
- Turnkey growth partner for sales, logistics and fiscal representation
Why do you need MDR/IVDR & MHRA Importing Services?
- Documentation & license review
- EU & UK importer representation
- Labeling & product registration
- Shipment verification & tracking
- Post-market surveillance & audit support
Import your Medical and IVD devices in Europe today. Opportunities for Growth in Europe!
More Ways We Help
What Our Clients Say
“We really appreciate the dedication and methodical approach by GrowthMedics team demonstrated in helping our registration and marketing in the EU market”
Luke Gao PhD
CEO Panacyte Scientific LLC.
“We have been working with Growth Medics to increase awareness of our software solutions in the Medical Device Industry. Growth Medics team have a deep knowledge and understanding or our industry and were very professional”
Louis Albert - CEO
“The team is diligent and professional in its approach to understanding our company and creating pathways to new markets. We recommend GrowthMedics as a partner to assist with European expansion plans”
Managing Director-Principal
“GrowthMedics’ team is highly strategic and experienced professionals. Their extensive knowledge of the global healthcare market, along with their targeted approach to business development, makes them a great asset to work alongside”
Kareem Sherif
“When working with the managing director of GrowthMedics, he was always incredibly helpful and understanding of our organizational needs regarding expansion in international markets. He took his time to understand our business and product offering to help provide tailored solutions aimed at taking our business to the next level”
Chad Gottschalk
“GrowthMedics played a vital role in our international development. Their network, team, experience and deep industry knowledge helped us grow our market share in Europe. By acting as our European sales arm, they have successfully established and managed a network of distributors and clinics across European markets”
Sebastien Lachapelle
“Expanding into new markets internationally recently has been especially challenging. GrowthMedics gets doors opened, is very efficient and follows through. We highly recommend GrowthMedics for their help expanding our footprint in Europe and MENA.”
J. Mark Strong
“ We are delighted to work with Growth Medics in developing the European Union market. The team have been most professional, diligent and committed to our joint success”
Max Kanarsky
What Our Clients Say
“We really appreciate the dedication and methodical approach by GrowthMedics team demonstrated in helping our registration and marketing in the EU market”
Luke Gao PhD
CEO Panacyte Scientific LLC.
“We have been working with Growth Medics to increase awareness of our software solutions in the Medical Device Industry. Growth Medics team have a deep knowledge and understanding or our industry and were very professional”
Louis Albert - CEO
“The team is diligent and professional in its approach to understanding our company and creating pathways to new markets. We recommend GrowthMedics as a partner to assist with European expansion plans”
Managing Director-Principal
“GrowthMedics’ team is highly strategic and experienced professionals. Their extensive knowledge of the global healthcare market, along with their targeted approach to business development, makes them a great asset to work alongside”
Kareem Sherif
“When working with the managing director of GrowthMedics, he was always incredibly helpful and understanding of our organizational needs regarding expansion in international markets. He took his time to understand our business and product offering to help provide tailored solutions aimed at taking our business to the next level”
Chad Gottschalk
Sebastien Lachapelle
J. Mark Strong
Max Kanarsky
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