FDA:

We support medical device companies seeking approval to sell their products in the United States.

 
The FDA 510(k) submission services we offer include:

• Verification whether a FDA 510(k) submission is the correct approach to obtain marketing approval for the device in question (mostly Class 2 devices);
• Find the predicate device(s) required for the submission or verify that those found by the customer meet the submission criteria;
• Decide on the type of 510(k) submission to follow (traditional, abbreviated, special);
• Look for any available FDA Guidance Documents and applicable standards;
• Provide the company with the list of documents required for the submission;
• Prepare the 510(k) submission file;
• Submit the 510(k) file;
• Coordinate the reply to (eventual) FDA questions;
• Answer the questions (eventually) posed by the FDA reviewer;
• Perform any necessary amendments to the file.

Likewise, we assist our customers with Premarket Approval (PMA) submissions to the FDA.

 
Health Canada:

We support medical devices companies seeking approval to sell their products in Canada.

Our services include:

• Upgrade the company Quality System to the Canadian national standard CAN/CSA ISO 13485 (CMDCAS);
• Verification of the device classification;
• Look for any applicable standards to the device in question;
• Provide the customer the list of documents required for the submission;
• Calculate the fees payable to Health Canada;
• Prepare the Medical Device License (MDL) submission file;
• Submit the MDL file to Health Canada;
• Coordinate the reply to (eventual) Health Canada questions;
• Answer the questions (eventually) posed by the Health Canada reviewer;
• Perform any necessary amendments to the file.