Quality Assurance Solutions

QMS/QSR Road Map and Documentation

  • ISO 9001: 2015
  • ISO 13485: 2016
  • 21CFR 820 QSR
  • ISO 14971 Risk Management
Gap Analysis and Remediation
Performance Evaluation
Post Market Surveillance
Usability Testing and Evaluation
Internal Audit
Quality Control Training & Support
Facility Clean Room Validations