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ISO 13485 consultants in South Africa

Medical-device quality management systems designed, implemented and kept audit-ready, starting with a gap audit.

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ISO 13485:2016 is the quality management standard built for medical devices, where regulatory rigour and traceable records are not optional. We build a system that holds up to that scrutiny (design controls, risk management and traceability) without burying your team in paperwork.

You can bring us in for consulting only, for consulting plus the iQuotient platform, or as the strategic layer around an existing system. The starting point is always a gap audit.

What we do

  • Scope, context and a quality policy mapped to your device and regulatory risk.
  • Design controls, device files, registers and document control your team will use.
  • Risk management, traceability, CAPA and post-market feedback processes.
  • Team training, rollout support and optional iQuotient onboarding.
  • Certification-body audit preparation: we get you ready to pass.

Is this you?

01

Regulators or customers require it

Market access or a buyer depends on a recognised medical-device QMS, and you need it built properly.

02

You design or manufacture devices

Your processes need to be controlled, documented and traceable to the standard the sector expects.

03

You supply or distribute devices

Storage, handling and traceability obligations sit with you too, and they need a defensible system.

Frequently asked questions about ISO 13485

What does an ISO 13485 consultant do?
We help you design, implement, maintain and improve a medical-device quality management system that meets ISO 13485:2016: design controls, risk management, traceability, CAPA and audit readiness, so you are ready for the independent certification audit.
Is ISO 13485 the same as ISO 9001?
No. ISO 13485 is a standalone standard for medical devices with stricter requirements for risk management, traceability and documentation, though the two share a common foundation. We build to 13485 specifically.
Does Synergy Consilium issue the ISO 13485 certificate?
No. We are your implementation partner. An independent, accredited certification body performs the audit and issues your certificate, and we prepare you to pass it.
Do I need ISO 13485 for medical devices?
It is widely expected for market access and is often required by regulators and customers as evidence that your device quality system is controlled. A gap audit confirms what your situation requires.
Where do we start?
Every engagement starts with a gap audit, so you can see exactly where you stand against ISO 13485:2016 before committing.
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Ready to start your ISO 13485 journey?

Contact us. We'll show you where you stand and the realistic, accredited path to certification.

Contact usor call +27 87 150 3022
087 150 3022