System and Procedure Packs in Accordance with EU MDR
In today’s healthcare system, the role of system and procedure packs is of great importance. Since these packs contain tools […]
EU MDR Compliance
Understand the EU MDR requirements for medical device manufacturers. Our articles cover conformity assessment, CE marking, safety documentation, and risk management to ensure products meet European standards.
Medical Devices Regulations in European Union (EU MDR)
EU MDR defines the conditions under which medical devices can be placed and maintained on the European market. Beyond certification,
Artwork Proofreading & Quality Check for Top-50 European Biopharma Clients
Artixio is helping pharmaceutical companies with their artwork and label compliance through proofreading and quality check services using manual as
Conformity Assessment of Medical Devices under EU MDR
EU MDR places clear responsibility on manufacturers to prove that their devices meet regulatory expectations. Conformity assessment is the mechanism
Regulations of Reusable Medical Devices under EU MDR
The introduction of the EU Medical Device Regulation (MDR) has brought increased emphasis on robust data and comprehensive evaluations for
Role of PRRC under EU MDR and IVDR
Compliance under EU MDR and IVDR is no longer managed in fragments. Instead, accountability has been concentrated into a clearly
Meeting EU Regulations: Role of the European Authorized Representative (EAR)
Placing a medical device on the EU market involves shared responsibility. For manufacturers outside the EU, part of that responsibility
EU MDR Labelling Requirements For Medical Devices
Labelling under EU MDR is no longer something manufacturers handle at the last stage. What goes on the label is