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Medical Device Registration

Attention to all professionals engaged in the production and distribution of medical devices destined for use within the United States. Ensuring your compliance with the FDA is paramount.

It's mandatory for medical device firms to register with the FDA annuallly during the crucial renewal period between October 1 and December 31 each year.

Our expert team is here to guide you through the process of FDA Medical Device registration quickly, efficiently and at low cost.

We can help with:

  • Medical Device Registration and Listing

  • Product Code Discovery

  • Acting as your US Agent

  • Submission & Filing Support
     

Don't miss the opportunity to maintain your FDA registration.

Book a call with one of our Consultants today to secure your registration and continue delivering innovative medical solutions to those who need them most. Get a Quote Now!

Get a Quote Now!
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Medical Device Registration 

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.

US Agent - Non US based businesses are required by law to have a US Agent to represent them with FDA for communications purposes. We provide this as part of our simple, no nonsense service.

Communication - We understand that when you have questions that your time is important. Whether it is an email response, phone call, getting on a Teams or Zoom call, we will get back to you fast to get you the information required and progress your registration.

Proven Track Record - 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.

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Low Cost

We offer competitive, fixed prices with no hidden costs.

Professional & Fast

Our expert team always respond in a timely fashion.

Personal Service

You get a named contact who will guide you through the process personally.

Register Your Facility and Medical Device Now

  • Medical Device Registration: We conduct thorough assessments of your specific needs on devices, strategize for compliance, identify the correct product codes, and provide guidance on every step of the registration and device listing process.
     

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

  • US Agent: Beyond registration, we provide ongoing support to ensure your devices maintain compliance once they are on the market through our US Agent service for non US domestic manufacturers and US based importers.

Our Partners

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We Help Save Time And Money. 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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