Our goal is to provide you with high quality documents and information required for worldwide medical device approvals. We specialize in active medical devices and software products. We can also provide services for non-medical electrical in the US, Canada and Europe.

Our product is the guidance and paperwork you need to have your device submitted and  “approved” so that it can be sold in the United States (510(K) Submissions), European Union (Technical Files for CE marking), and Canada (license applications to the Canadian TPD).
Aside from actually doing the paperwork required for submission / “approval”, we can assist in identifying requirements. We can provide advice on:

• Electrical safety (IEC, UL, CSA)
• Electromagnetic compatibility (EMC)
• Performance testing
• Standards compliance for US, Canada, European Union, and elsewhere.

We can also assist with the process requirements needed for actually selling your products:

Identify the quality standards required

• US "site registrations and listings"
• EU Notified Bodies
• EU Representatives and similar requirements