Quality Assurance

Navigating the Regulatory Landscape with Precision and Purpose. Your trusted Partner for Regulatory Services across Africa.

At PNS Med Health, our ambition is to turn regulatory complexity into clear, actions for medical device decision-makers. With deep insight in both local African markets and global regulatory frameworks, we support clients in navigating evolving requirements, fragmented regulations, and cross-border compliance challenges — streamlining the path to approval and enabling confident market access.

Services


Quality Management System Development:

  • Full QMS Design & Implementation (ISO 13485 /
    FDA QMSR, MDSAP)
  • QMS Gap Assessments & Remediation
  • Supplier Auditing and Internal Auditing
  • Training Programs & Competency Development
  • Certification Preparation & External Audit
    Readiness

Territory Specific Compliance

  • Gap Assessment and Compliance Roadmap
  • Safety and Performance Requirements Alignment
  • QMS Upgrades to Meet Specific Regulatory Requirements