Medical Devices

Setting a clear path to regulatory approval

 

Safis Solutions recognizes the importance of timely product approvals. Product delays can affect everything from your bottom line to patient outcomes.

 

We work with your staff to expedite the approval process whether you need extra hands, strategic planning advice, or both.

 

  Medical Device Compliance Regulatory

 

Guiding You Through the Regulatory Path

 

If you aren’t sure of your next steps, turn to Safis Solutions. We will determine what you need to do and develop a regulatory strategy that will get you to market as quickly as possible.

 

Because we have experience with a full range of devices (including patient-specific medical devices and IVDs), we understand the nuances of your potential regulatory requirements, including:

 

  • Unique Device Identifier regulations
  • FDA clearances or approvals such as 510(k), PMA, IDE, HDE, etc.

Helping You Get Your Medical Device into Other Countries

 

A key reason why many companies work with Safis Solutions is because of our global regulatory experience. We can help with OUS registrations on 6 out of 7 continents. In particular, we can assist with:

 

  • EU Technical Files and Renewals
  • CFDA Import Licenses
  • Clinical Evaluation Reports (CERs, , clinical evaluations)

     

If you are an international company wanting to market your product in the U.S., we can help you as well. To enter the United States market, you must have a U.S. citizen work with the Food and Drug Administration to ensure that the product meets the FDA’s standards of quality. Safis Solutions can serve in that role.

 


Supplementing Your Internal Resources

 

Regulatory compliance is a big job. Even if you know what you need to do, sometimes you simply don’t have enough people to get it all done. When you need extra hands, think of us as your virtual regulatory compliance team. Give some or all of your work to us and we’ll get it done.