If you are a medical device manufacturer considering entering the U.S. market, and you want to market your product, you must understand how and when to file the 510k application. If submitted too early, it can add to delays, more costs, or even recalls; submitted too late, it cannot be included in subsequent batches. At…
DetailsAt present, the healthcare industry in Saudi Arabia is quickly developing. While the global demand for reliable medical supplies grows significantly, it is critical to establish the medical devices’ safety and effectiveness. This is where ISO 13485 certification in Saudi Arabia can come into the picture and offer a standard model for the organizations that…
DetailsHIPAA Compliance and US FDA HIPAA – The Health Insurance Portability and Accountability Act 1996. It is a set of standards introduced by the U.S. Congress consists of rules governing protected health information (PHI) including Security, Privacy, Identifiers, and Transactions and Code Sets. It promotes the protection and privacy of sensitive PHI used within the…
DetailsThe Single Registration Number (SRN Number) identifies every economic operator in EUDAMED and outside of EUDAMED. The Actor registration module enables economic operators to submit, by means of an actor registration request, the information necessary to obtain a single registration number (SRN). The SRN is issued once the relevant competent authority has validated the Actor registration request.
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