Support for the certification of medical products

• CE-Marking of your medical products in Europe (93/42/EEC)
• 510k of your medical product for FDA / USA
• Implementation of a quality management system in your company (ISO 13485)
• Providing the quality management representative for small companies

Development of medical devices

• Development process (ISO 13485)
• Technical expertise on medical lasers, fibre optics and clinical application
• Project management
• Implementation of a risk management process (ISO 14971)
• Moderation and Conduction of a risk analysis
• Clinical evaluation (acc. to MedDev 2.7.1 rev. 4)