Case Study:

Australian Medical Device Company Seeks Help from Safis on 510k Approval


Our Client:

An Australian medical device company engaged Safis to review their 510(k) submission and serve as its representative agent with the FDA for their first U.S. 510(k) submission.



Safis successfully performed a review of the 510(k) file and identified areas of clarification and improvement in order to provide the FDA with the most complete and accurate 510(k) submission possible. The 510(k) was submitted to the FDA within the company’s desired timeframe.


Safis continued to provide services to review and submit the company’s responses to the FDA response, as well as participate in a conference call with the FDA to address the FDA response to the 510(k) submission.


Safis worked with the client to provide all necessary information to the FDA in order to obtain 510(k) approval.