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

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Global Regulatory Insight and Compliance:

• Global Market Insights, Pathway Strategy &
  Market Access Planning
• Business / Product Registration & Submission
  Support
• Regulatory Requirements Training, Workshops
  and Capacity Building

Post Market Surveillance and Vigilance Activities:

• PMS System Development & Implementation
• PMS Periodic Reporting & Documentation
• Global Vigilance Monitoring Activities
• PMS and Vigilance Training & Capacity Building

Licensing & Market Authorization:

• Regulatory Classification & Pathway
  Determination
• Establishment Licensing & Registration (South
  Africa, Africa, and international markets)
• Due Diligence & Compliance Verification

Technical File Preparation & Dossier Submission:

• Full Technical Documentation & Dossier
  Development (Global and Country Specific)
• Clinical & Product Performance Evidence
• Risk Management Documentation (ISO 14971)
• Labelling & IFU Compliance

MDR 2017/745 Compliance

• MDR Gap Assessment & Compliance Roadmap
• General Safety & Performance Requirements Alignment
• Clinical Evaluation (CEP/CER) & PMCF Activities
• PMS, PSUR & Vigilance Compliance (Annex III)
• EUDAMED Readiness
• QMS Upgrades to MDR Requirements
• Economic Operator Compliance
• Notified Body (NB) Coordination & Audit Support
• Technical Documentation preparation