MedApprove

United States: FDA Premarket Notifications 510(K)

• Creation and submission of 510(k). We will follow through until clearance
• Research predicate devices
• Research applicable guidance documents
• Research applicable consensus standards
• Determine type of submission - traditional, abbreviated or special
• Help with device descriptions, intended use, labeling, instructions for use
• Guidance on electrical safety and Electro-Magnetic Compatibility (EMC) testing
• Provide guidance on applicable standards (as well as consensus standards if they exist)
• Guidance on classification, listings, site registration

Create and submit license applications to Health Canada’s Therapeutic Products Directorate. Will follow through until receipt of license  Help with device descriptions, intended use, labeling, instructions for use, guidance on testing, etc. Guidance on electrical safety and Electro-Magnetic Compatibility (EMC) testing. Provide guidance on applicable standards Guidance on device classifications Advise on license amendments