HIPAA 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.
DetailsMedical devices that must be sterilized before use, appropriate sterilization cycle parameters must be determined through a sterilization validation process. Medical device sterilization validations are one of the prime aspects of medical device testing as an improper sterilization method could lead to severe patient consequences or even patient death.
DetailsPremarket Approval(PMA) is one of the FDA processes of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
Details
