Medical Devices enrich our life at an increasing rate. The intended chief virtue is physically in comparison to medicinal products, but substances with pharmacological or immunological effect might enhance the physical effect of medical devices. The life-cycle management of medical devices is also be planned and documented comprising the development, manufacturing, putting into circulation and into operation, the implementation, maintenance and the use. Medical devices are a complex product group which is classified concerning the effect and the benefit-risk-ratio. The classification affects the conformity procedure in the meaning of technical documentation and the mode of quality management system.  

Overview about Medical Devices activities:

• Classification and demarcation - consultation, implementation and expertise
• Medical device registration procedure, CE marking
• Liaison with Notified Bodies/Competent Authorities
• QM-system and risk management in medical devices
• Medical Device Vigilance