info@isocertification.cd +243815855557
108 Avenue TSF Quartier Golf Commune de la Gombe - Kinshasa Language: EN FR

ISO 13485:2016

Medical Devices Quality Management Systems for regulatory compliance in the healthcare sector.

Business Benefits in DRC

Compliance with medical regulations
Improved product safety
Global market access for medical devices

Service Scope

  • Gap Analysis
  • Policy and Procedure Documentation
  • Risk Assessment Matrix
  • Internal Auditor Training
  • Pre-Certification Audit
Request Quote for ISO 13485:2016 General Inquiry