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Medical Device Registration

The FDA (U.S. Food and Drug Administration) sets stringent requirements to ensure the safety and quality of food imported into the United States. Our expert team is here to guide you through the intricacies of FDA compliance and food importation.

We can help with:

  • Medical Device Registration Assessment

  • Document Preparation

  • Submission Support

  • Post-Market Compliance
     

We have helped hundreds of clients successfully register their medical devices.

 

Get in touch to start exporting your products to the United States

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Medical Device Registration 

Unparalleled Expertise in Medical Device Regulations - Our team is composed of industry veterans with extensive knowledge of medical device regulations. We are well-versed in deciphering complex regulatory language and implementing these standards to guarantee that your medical devices align with all required criteria.

Comprehensive Registration Services - We offer an extensive array of services designed to cater to your unique needs, regardless of whether you're a start-up or an established company. Our services encompass everything from initial assessments and strategy development to meticulous document preparation and timely submission.

Navigational Guidance - Understanding the ever-evolving regulatory landscape can be daunting, especially in the realm of medical device registration. We excel in simplifying the process by offering comprehensive guidance, ensuring that your devices seamlessly meet all regulatory prerequisites.

Proven Track Record - Our track record speaks volumes about our proficiency. We have successfully assisted numerous medical device companies in achieving seamless registrations and market entries, and we're here to do the same for you.

Our FDA Compliance Services

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FSVP Agent Services

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US Label Reviews

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FDA Registration

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Dietary Supplements

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FDA Import Removals

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Seafood HACCP Review

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Juice HACCP Reviews

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Amazon Food Sellers

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Lowest Cost

We offer the most competitive prices on the market whilst maintaining the highest standards. we are food safety experts and not lawyers

Proffesional & Fast

All of our services are carried out by Preventative Controls Qualified Individuals (PCCQI's) who will ensure full compliance

Online Service

Our bespoke and unique software allows us to complete FDA services, quickly, reliable at low cost and with full traceability.

Register Your Medical Device Now

  • Medical Device Registration Assessment: We conduct thorough assessments of your specific devices, strategize for compliance, and provide guidance on every step of the registration process.
     

  • Document Preparation: We meticulously prepare all requisite documentation for your medical device registration, ensuring nothing is overlooked.
     

  • Submission Support: We offer unwavering support during the submission process, ensuring that your registration application is precise and comprehensive.
     

  • Post-Market Compliance: Beyond registration, we provide ongoing support to ensure your devices maintain compliance once they are on the market.

Our Partners

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We Can Help Save You Time. Contact Us Today

Ready to ensure your medical devices meet all regulatory requirements and are poised for market success? Contact our experts today for personalized assistance with medical device registration and compliance.

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