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.
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We can help with:
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Medical Device Registration Assessment
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Document Preparation
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Submission Support
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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
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.
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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.
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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.
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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
FSVP Agent Services
US Label Reviews
FDA Registration
Dietary Supplements
FDA Import Removals
Seafood HACCP Review
Juice HACCP Reviews
Amazon Food Sellers
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
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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.
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Document Preparation: We meticulously prepare all requisite documentation for your medical device registration, ensuring nothing is overlooked.
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Submission Support: We offer unwavering support during the submission process, ensuring that your registration application is precise and comprehensive.
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Post-Market Compliance: Beyond registration, we provide ongoing support to ensure your devices maintain compliance once they are on the market.
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