10123 Torino ()
Contact person: Alice Ravizza
Phone: 0039 3493621829
Founding Year: 2012
Employees in R&D: 0
Fields of business: Medical devices / Biotech Healthcare, Others
Regulatory, quality assurance.
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
- Sterilization and packaging of medical devices