Wherever you are in your product development lifecycle,
Sterling can help.
The EU Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) that has been the standard for medical device regulation in the EU since 1993. If you need help to update your documentation from MDD to MDR/IVDR compliance, Sterling can help. Under the MDR, your CER and PMCF are live documents that must be routinely updated. Sterling can help update these documents as well.
Before bringing a medical device to market in the EU and other parts of the world that follow CE Mark regulation, it is essential to determine applicable regulatory requirements it must adhere to ensure patient and user safety. Sterling’s regulatory team offers services to help you identify and address key CE Mark requirements for your device including:
September 21, 2023
February 18, 2021
November 23, 2020