What we
do great
We offer Regulatory and Quality Management System (QMS) consulting services.
Our approach is to design, implement and maintain custom-made integrated QMS models in compliance with the local and essential global regulations.
Our service includes creation, update, implementation, and maintenance, verification of effectiveness of the requested sub-systems to build up an integrated QMS, alongside training and auditing.
The services assure compliance with:
THE NEW EU MEDICAL DEVICE REGULATION (MDR)
MDSAP PROGRAM
QUALITY SYSTEM UNDER EN ISO 13485, US FDA QSR - GMP
DESIGN CONTROL UNDER EN ISO 13485 & 21 CFR PART 820
THE LITERATURE ROUTE FOR CLINICAL EVALUATIONS
APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
PROCESS VALIDATION INCLUDING SOFTWARE
Our Services
Explore our comprehensive range of regulatory and quality management services
