Ringby Regulatory Affairs

Risk Management according to:

EN ISO 14971:2007, Medical devices - Application of risk management to medical devices

Biological Evaluation according to:
EN ISO 10993-1:2003, Biological evaluation of medical devices
EN ISO 10993-17:2003, Biological evaluation of medical devices - Establishment of allowable limits for leachable substances
EN ISO 10993-18:2005, Biological evaluation of medical devices - Chemical characterization of materials
Etc.
Quality Management according to:
EN ISO 9001:2000, Quality Management Systems - Requirements
EN ISO 13485:2003, Medical Devices – Quality Management Systems
EN ISO/IEC 17025:2005, General requirements for the competences of testing and calibration laboratories