MEDICAL DEVICE REGULATION SERVICES
PRESALES ASSISTANCE RELATED TO MDR
* ISO 13485 Quality Management System Certification Consultancy
* CE Technical File Consultancy
* Risk Management (ISO 14971:2019) Consultancy
* Medical Devices Clinical Follow-up (PMCF)
TESTING & VALIDATION SERVICES
* Toxicological Risk Assessment (BER)
* Inspection
* Validation
* After Sales Inspection (PMS)
* UDI
IN VIVO TESTING CONSULTANCY
* Biocompatibility Test Service
