We provide consulting, training and system development for Medical Devices companies in order to obtain compliance to ISO 13485 and Medical Device Directive. Special focus on start-ups and leading innovative companies. We strive to assist companies to implement a lean and cost effective system for ISO 13485 compliance and Product CE marking.

Full bilingual issue of all documents in Italian and English.

Our specialties include:

• Quality Management System implementation, CAPAs, Risk Management
• CE mark for medical devices
• Product and Process validation and Risk Management
• Full CRO services for Medical Devices: pre-clinical trials, clinical trials and clinical follow up Implantables
• Animal tissues use in Medical Devices
• Electro-medical devices
• Disposables
• Sterilization and packaging of medical devices