O ur ISO 13485 consultants have hands-on expertise setting up quality management system for medical devices designers, manufactures, exporters and traders, service establishments and testing laboratories. By providing consultation, access to sample documentation, and online resources, we will walk you through the process. We can support you with your ISO 13485 Certification assessment and assist [...]
B iological safety of the medical device is an important requirement for market approval. It is important for a medical device manufacturer to evaluate the potential risk of a medical device to a patient or user. This evaluation alone does not suffice, the medical device manufacturers need to address the potential risk of the [...]
SRN for Medical Devices: The Single Registration Number (SRN Number) identifies every economic operator in 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 [...]
