Electronic records are everywhere these days - healthcare providers, patients, and now event manufacturers face that change. More and more pharmaceutical and medical device companies are preparing to submit applications to regulators electronically.
The healthcare IT standards organization Health Level Seven International (HL7) is creating a standard that will include guidelines on how to submit applications electronically for regulated drugs and medical devices to authorities around the world.
The most recent issue of AAMI News reports that HL7 plans to test the regulated product submission (RPS) in the fall of 2011, and the International Organization of Standardization plans to adopt the standard as early as 2013.
For More Information please click here: e-submissions look scary?
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