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Filing a MAF for Arrhythmia Algorithm Software with the U.S. FDA


Filing a medical device master file (MAF) for Arrhythmia Algorithm Software can be a useful mechanism to market your Arrhythmia Algorithm Software to the U.S. Medical Device Industry. Typical Arrhythmia Algorithm Software producers who have filed a MAF for Arrhythmia Algorithm Software include:

  - HEWLETT-PACKARD CO.

Registrar Corp can help you to properly prepare and submit your Arrhythmia Algorithm Software MAF to FDA.

As your Agent, Registrar Corp will perform the following administrative functions:

  - Ensure administrative accuracy of your Arrhythmia Algorithm Software MAF
  - Format, assemble and deliver your Arrhythmia Algorithm Software MAF to FDA
  - Assist with preparing letters of authorization regarding your Arrhythmia Algorithm Software MAF
 - Provide changes, additions and maintenance of your Arrhythmia Algorithm Software MAF
  - Respond to issues relating to ownership of your Arrhythmia Algorithm Software MAF
  - Assist with submission of responses to FDA concerning your Arrhythmia Algorithm Software MAF

For more information about filing a MAF for Arrhythmia Algorithm Software, simply click below:




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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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