FDA 510K International Process

FOR OUR INTERNATIONAL CLIENTS

We assist you with obtaining the small business discount, when possible per your countries rules and regulations.

We can be your U.S. Agent if necessary for your device once it is cleared and is sent to the U. S. market.  To make things easier for you, we have a contract/form with the additional information about the U.S. Agent’s responsibilities.  If you need our services in this area please print off the contract, sign and return to the email address listed at the bottom of the form.

   U.S. Agent Contract

 


 

International Time Differences

We have many international clients.  Due to the time differences, we handle this work through the internet with emails.  This has proven to be a good method due to the language differences and all of the work we do requires forms and information from the client.  Most of the FDA work is handled in this method, as well.

 Contact:  Joyce@510kDA.com

 

510k FDA Consulting has a working relationship with CE Medical for our international clients or those in the U.S. that plan to take their device to Europe.  You may contact Joyce for assistance with a point of contact with CE Medical, or you may contact them directly.  Just be sure to mention you have been referred by 510k FDA Consulting and they will take exceptional care to service you.                                                                   

 

CE Medical, is a technical and legal certification company specialized in the CE Marking of Medical Devices. CE Medical has expertise in all procedures required to arrive at a successful CE marking certification and offers full assistance to gain the CE Mark for your Medical Device products.

WE ASSURE COMPLIANCE FOR THE FOLLOWING PRODUCTS

SELECTION OF THE PRODUCTS WE HAVE CERTIFIED:

  • Wheelchairs
  • Crutches
  • Eyeglasses
  • Injections
  • Heart monitoring equipment
  • Anesthesia devices
  • Beds
  • X-ray devices

Medical Device products must be CE marked before they can be legally put into use in Europe. Based on your (technical) product information, the specialized technical and legal certification experts of CE Medical will be able to provide you with a custom made price indication and timeframe within 24 hours.

 

 

For direct support regarding CE Marking of a Medical Device you can contact CE Medical by calling +31 (0)294 48 33 55 or email us at  info@ce-mark-medical.com.

 

Certification Experts is an international organization that is specialized in CE marking, European Product Safety legislation, International Product market access, and technical and legal regulatory compliance issues.

 

Certification Experts provides their expertise to designers, manufacturers, exporters, importers, distributors and various other organizations and individuals in order to ensure that they meet all requirements needed for compliance with European Union Product legislation, International Regulations and regulatory affairs.