
10123 Torino ()
Contatto: Alice Ravizza
Ruolo: Owner
Email:
Telefono: 0039 3493621829
Sito http://www.pggscientific.com
Anno di Fondazione: 2012
Impiegati: 1
Impiegati R&D: 0
Settori di attività:
Medical devices / Biotech Healthcare, Others
Keywords:
Regulatory, quality assurance.
Descrizione
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