Our Core Services
Six Specialist Services.
[01]
[01]
Build the right product pathway before committing to a submission.
We assess intended use and risk classification, identify technical documentation gaps, review labelling and instructions for use, and support product listing or registration preparations where applicable under South Africa’s evolving regulatory framework.
Our capabilities include:
[02]
[02]
The licence held by an establishment must match the activities it performs.
We support SAHPRA manufacturer, distributor and wholesaler licence applications, including documentation preparation, quality-system alignment, renewals, amendments and product-list updates.
Our capabilities include:
[03]
[03]
A quality management system should be auditable, proportionate and usable.
We support ISO 13485-aligned QMS implementation, quality manuals, standard operating procedures, supplier controls, corrective actions, internal audits and preparation for independent certification assessments.
Our capabilities include:
[04]
[04]
Regulatory obligations continue beyond an initial submission.
We provide medical device and IVD regulatory strategy, compliance gap assessments, regulatory intelligence, product lifecycle management, authorised representative support where appropriate, and post-market compliance planning.
Our capabilities include:
[05]
[05]
Verion Medical provides import, export and distribution operations to support medical device manufacturers and suppliers entering and operating in the South African market.
Our services encompass regulatory import and export compliance, shipment documentation, logistics coordination, product traceability and distribution controls, supporting efficient and compliant access to the South African healthcare market.
Our capabilities include:
[06]
[06]
Market access requires more than regulatory preparation.
We support route-to-market planning, distributor and channel assessments, market-development strategy, product launch coordination, tender readiness and focused commercial growth initiatives for medical device and IVD businesses.
Our capabilities include:
The Verion Approach
How we work.
Every engagement is shaped by your product, business model and commercial objectives. We provide focused specialist support or integrated services across the medical device and IVD market-entry lifecycle.
1
We Assess
We evaluate product classification, regulatory requirements, existing approvals and business activities to establish a clear starting point.
2
We Prepare
We define the regulatory pathway and prepare the necessary licensing, technical documentation and quality management requirements.
3
We Execute
We support regulatory submissions, import, export, distribution operations and market-entry activities in line with your business objectives.
4
We Maintain
We support ongoing regulatory compliance, licence maintenance, quality systems and post-market obligations as your operations evolve.
Who We Support
From established international manufacturers to South African distributors and emerging medtech companies, our work is shaped by the client’s product, role and operating model.
Planning to Enter the Medical Device Market?
Before You Get Started
FREQUENTLY ASKED QUESTIONS
Our Thinking
News & Insights
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ISO 14971 Risk Management for Medical Devices: Practical Requirements
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Winning a medical device tender in South Africa starts long before the bid submission date.…
Unsure Which Service Your Business Requires?
Tell us about your requirements. Our specialists will assess your needs and recommend the most appropriate services.