1. Med Health 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 