Quality & traceability
How we control every device, stated plainly. If something isn’t confirmed yet, we say so.
Designs and manufactures the product families Vertevance imports and supports in South Africa.
Establishment licensing, device registration and vigilance, managed within the South African regulatory framework.
Imports, stores, tracks and supports each device locally, and is the first point of contact for a South African hospital or surgeon.
Retain full clinical responsibility for patient selection, technique and outcome.
Every manufacturing partner is qualified before a product from them reaches a shelf.
Every implant is tied to a case, a batch and a site from the point it arrives in the country.
Technical files, instructions for use and specifications are version-controlled and reviewed before publication.
Representative training and theatre credentialing is recorded and kept current against each hospital's own requirements.
A defined, documented route exists for reporting a product complaint or adverse event, kept separate from sales enquiries.
Every unit is tied to a case and a site, so a recall starts with records we already hold. No one has to reconstruct them.
Four habits that turn a recall into a quick lookup.
Traceability is only useful at the unit a question is actually asked about: this implant, in this case, at this hospital, on this day. That is the level the record is kept at.
We log each implant and instrument set against the case it was used in, not just the shipment it arrived in.
We capture batch and lot details in theatre, at the point of use.
Stock on hand is reconciled against the current stock record as part of case close, so a shortfall is caught early.
A manufacturer recall notice can be matched against every affected case and site from the existing record, without a search started from scratch.
Regulatory status
Vertevance Medical has submitted an application to SAHPRA for a medical-device establishment licence as an importer and distributor. The application is awaiting an outcome; submission is not approval or the issue of a licence.
Application and supporting documents compiled.
With SAHPRA, awaiting an outcome.
We’ll update this page when SAHPRA decides.
Our next two steps: certified quality management, and a home of our own in Johannesburg.
ISO 13485 is the international standard for quality management in medical devices. We’re building our processes, records and controls to meet it, and working towards certification.
We’ll update this page when certification is granted. Until then, we don’t claim it.
A dedicated site for stock, kit preparation and dispatch, built around the same controls. It brings our stock closer to the hospitals we serve and shortens the time from request to theatre.
