• Do you have a “me-too” medical device that is FDA Class II?

  • Are you ready to submit your supporting documentation?

  • Unsure of which type of 510(k) application to submit?

  • Need to discuss compliance issues with FDA prior to submission?

 

 
Companies located worldwide can benefit from Gemar assistance and support in understanding and responding to U.S. product submission requirements.
 
 
GEMAR can help your company to obtain FDA marketing clearance for Class II products by:
 
 
  • Assisting you in understanding U.S. submission requirements;
  • Providing support and advice during 'pre-sub' communications with FDA;
  • Developing 'Traditional', 'Abbreviated' or 'Special' 510(k) submission documentation which meets FDA expectations, incuding 'eCopy' and 'Refuse to Accept' (RTA) requirements;
  • Identifying and obtaining applicable guidance documents and identifying FDA-recognised consensus standards;
  • Assisting in the development of labeling, including user manuals, that meets U.S. regulatory requirements; and
  • Helping with company registration and device listing.