At PNS Med Health, we specialize in strengthening the medical device landscape through expert regulatory guidance, quality systems development, global compliance support and the responsible supply of trusted medical technologies.
Based in South Africa, with a global mindset, we provide the technical depth, regulatory intelligence and operational excellence needed for companies to compete confidently in international markets.
Our business is built on two complementary divisions:
1. MedHealth Regulatory Intelligence & Compliance Services
This division delivers high-level regulatory strategy, global market readiness and compliance support for medical device and IVD manufacturers, importers and distributors. We help businesses navigate the complexities of ISO 13485, MDR/IVDR, FDA QMSR, MDSAP, SAHPRA, and other territory-specific regulations with clarity, precision and confidence.
Our services include:
- Global regulatory insight and market access strategy
- Technical documentation, GSPR alignment and dossier preparation
- MDR & IVDR compliance implementation
- Post-market surveillance, vigilance guidance and clinical/performance evaluation
- External auditing, gap analysis and certification readiness
- QMS development, optimization and digital transformation
- IT-enabled solutions for labelling, e-documentation and cross-border communication
- Training and capacity building for regulatory and quality teams
We serve as an extension of your organization — bringing the expertise, structure and global knowledge needed to elevate compliance, streamline operations and support sustainable market growth.
2. Med Health Supply & Distribution
Our supply division focuses on the responsible sourcing, importation and distribution of medical devices, diagnostics and health technologies that meet international quality and safety standards.
Through strong partnerships and a commitment to quality assurance, we ensure that healthcare providers and distributors in Africa have access to reliable, approved and compliant products.
We integrate regulatory oversight into the entire supply chain — from manufacturer due diligence and supplier auditing to product registration, labelling and lifecycle monitoring — ensuring that every product we deliver meets the highest regulatory expectations.
PNS MED HEALTH 