Consultation Services
- Feasibility studies for factories and projects
- Cost reduction projects
- Build medical devices factories
- Purchasing machines and production line with the best cost profit
- Preparation of laboratories chemical, physical and microbiological
- Establishment ISO 13485 and CE mark management system
- Market studies
Consultation Services
- Technical file preparation for medical devices
- Risk management for product and processes
- Clinical evaluation reports for all medical devices products
- Biocompatibility evaluation reports
- Gap analysis and assessment
VALIDATION SERVICES
- Carry out clean rooms validation according to ISO 14644-1
- Carry out sterilization process validation which includes:
- Sterilization by ETO according to ISO 11135
- Sterilization by Gamma radiation according to ISO 11137
- Software validation Carry out biocompatibility studies in accredited lab
- Carry out stability and package test validation in accredited lab
Training services
- Carry out training activities for all ISO and management standards (ISO 9001, 14001, 45001, 50001, 22001)
- Risk management according to ISO 14971:2012
- Clinical evaluation training according to Meddev.
- ISO 13485 implementation and requirements
- CE mark MDD and new MDR requirements
- Soft skills training
CERTIFICATION Services
- We can support companies to get quality management certificates
- We have agreement and agent for HTCERT and RINA Italy co. for ISO 9001, ISO 13485 and CE