Especially the critical incidents with poor quality breast implants in 2012 have lead to a more intensified demand by competent authorities and notified bodies to more thoroughly implement regulatory requirements for Medical Devices, such as the implementation of an effective quality system e.g. ISO 13485.
As another example this heightened regulatory attention to quality is reflected by the European Commission publishing recommendations for audits and audit evaluations (24. September 2013), demanding that unannounced audits be performed.
For years we have been engaged in the effective and customized realization of regulatory requirements for medical device manufacturers, and can advise and support You competently in all questions of medical devices quality assurance.