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…
The 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.
Medical 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.
Process validation means establishing objective evidence that a process consistently produces a result or product that meet its predetermined specifications.
Transport validations are performed to examine the suitability of packaging compatibility and safety. The transportation and the storage must not affect the properties of the medical devices i.e, the device must be damage free, maintain sterility, no physical damage, no biological contamination and function as intended.
Risk analysis, or hazard analysis, is a structured tool for the evaluation of potential problems which may be encountered in connection with the use of a medical device. Manufacturers are expected to identify possible hazards related with the design in both normal and fault conditions. If any risk is identified as unacceptable, it should be reduced to acceptable levels by appropriate means. To control risk there is term called as Risk Control.
Medical Device Labelling is the means to communicate information related to the safety and the performance of the device to the users which includes the proper identification of the device or group of devices too. It helps the end user to use the device as intended by the manufacturer.
Every medical device is labeled with an expiry date that is supported by shelf-life data. Shelf life is the time period during which a medical device remains suitable for its intended use. An expiration date mentioned over the labels is the termination of shelf life, after which a percentage of the medical devices, may no longer function as their intended use.
US FDA does not issue any type of Certificates to any organization stating registration or Listing successful.
The UDI is a series of numeric or alphanumeric characters created through a globally accepted device identification and coding standard. It allows identification of a medical device on the market. The UDI comprises of UDI-DI and UDI-PI.