Consulting

We add value to our customers providing consulting and advising services in our areas of expertise

Quality Management

  • ISO 13485 and ISO 9001 Quality Management Systems
  • Root Cause Analysis
  • Corrective and Preventive Actions
  • Process Validation
  • Validation of Support Systems and Software
  • Process Control
  • Statistical Methods
  • ISO 14971 Risk Management
  • Environmental and Microbiological Control
  • Sterilization of Medical Devices

    • Regulatory Affairs

  • FDA Regulations: QSR, GMP, Part 11
  • European Union Regulations, MDD, MDR
  • Regulations of Canada, Japan, Brazil, Australia and Costa Rica
  • Regulatory Submissions
  • CE Mark
  • Preparation and administration of regulatory inspections
  • Classification of Medical Devices