We know the SAHPRA mandate puts real pressure on your business. SHEQhub is a purpose-built QMS platform designed to make compliance straightforward and affordable.
Need hands-on help? Our ISO 13485 consultants work directly with you — from gap analysis through to ongoing compliance. Software, expertise, or both — we have you covered.
Your team already knows your business — SHEQhub gives them the tools to manage your QMS.
Read more ↓Already have a consultant? Give them a powerful QMS software platform to work on alongside your team.
Read more ↓Need expert help? Our ISO 13485 consultant works directly with you to get you certification ready.
Read more ↓SHEQhub manages your ISO 13485 compliance end-to-end — keeping you certification ready all the time.
Read more ↓Every company is different. Whether you have internal expertise or need hands-on support, we have a flexible option that fits your capacity, budget, and timeline. All options include full access to the SHEQhub QMS platform.
You + SHEQhub + Your In-House Team
Read moreCloseYou + SHEQhub + Your Consultant
Read moreCloseYou + SHEQhub + Our In-House Consultant
Read moreCloseSHEQhub Manages Your ISO 13485 Compliance
Read moreCloseYour team already understands your business — they just need the right tools. SHEQhub gives them a purpose-built digital platform to build, manage, and maintain your Quality Management System without the usual complexity.
Your team takes full ownership — from running a gap analysis and developing procedures through to training staff and managing internal audits. SHEQhub handles the heavy lifting with built-in document control, non-conformance tracking, scheduled tasks, and audit tools, all from a single cloud-based platform. This option is ideal for organisations that already have quality management experience or a dedicated compliance team in place.
You already work with a trusted quality consultant — great. Give them a powerful digital platform to work on. SHEQhub provides the QMS software to organise, manage, and maintain all documentation and compliance activities in one place.
Your consultant brings the ISO 13485 expertise — developing your documentation, conducting gap analyses, training your staff, and keeping everything on track. SHEQhub complements their work by providing the centralised digital platform where all documents, forms, signatures, and audit records are stored and managed. Your consultant gets direct access to the platform, enabling seamless collaboration between your team and theirs.
Don’t have a consultant? No problem. Our ISO 13485 consultant works directly with you and your team to get you certification ready — using the SHEQhub platform every step of the way.
Our consultant guides you through the full process one-on-one — from gap analysis and QMS documentation through to staff training, internal audits, and final audit preparation. Everything is built and managed on SHEQhub, so you have full visibility, a complete digital record, and a working QMS from day one.
Don’t want to manage compliance yourself? Let SHEQhub handle it for you. With our Outsourced Solution, we take full responsibility for building, managing, and maintaining your ISO 13485 Quality Management System — so you stay certification and audit ready at all times.
This is a continuous, hands-off service. Our team manages your QMS end-to-end — keeping documentation current, scheduling and conducting internal audits, managing non-conformances and corrective actions, running management reviews, and ensuring your system is always aligned with ISO 13485 regulations. When a audit or recertification audit comes around, you are already prepared — no last-minute scramble, no gaps. You focus on running your business while we keep your compliance in order.
Not sure what ISO 13485 actually involves? You are not alone. Here is a straightforward breakdown so you know exactly what you are dealing with.
ISO 13485 is the internationally recognised standard for Quality Management Systems (QMS) specific to the medical device industry. It outlines the requirements for organisations involved in the design, production, installation, and servicing of medical devices.
Unlike general quality standards (such as ISO 9001), ISO 13485 is purpose-built for medical devices, with a strong emphasis on regulatory compliance, risk management, and traceability throughout the product life cycle.
In South Africa, SAHPRA (the South African Health Products Regulatory Authority) has mandated that all companies involved in the life cycle of medical devices — from manufacturers and distributors to importers and sterilisation services — must hold a valid ISO 13485 certificate. This applies regardless of your company size.
We know this can feel like a heavy burden, especially for smaller operations that never expected to need a formal QMS. The good news is that with the right tools, compliance is manageable. SHEQhub was designed specifically to help companies like yours meet the requirement without the usual cost and complexity.
A QMS is a formalised system of processes, procedures, and documentation that ensures your organisation consistently meets quality and regulatory requirements. Think of it as the operational backbone that governs how you do things — from document control and training records to handling complaints and managing risk.
SHEQhub provides the digital platform to build, manage, and maintain your QMS — replacing paper-based systems and spreadsheets with a centralised, auditable, cloud-based solution.
ISO 13485 requires involvement from across your organisation. Top management must demonstrate leadership and commitment. You will also need a Quality Manager or Representative to oversee the QMS, and relevant staff need to understand their roles within the system.
That said, you do not have to figure it all out alone. SHEQhub makes it easy to assign responsibilities, track training, and keep everyone aligned — and if you need hands-on support, we can connect you with an experienced consultant who works alongside you on the platform.
The timeline depends on your company size, complexity, and how much of your QMS is already in place. As a general guide: small companies can typically work through the process in 4–8 months, while larger organisations may need 8–14 months.
SHEQhub helps you move faster by giving you a structured platform with built-in document control, audit tools, and task management — so you are not starting from scratch with spreadsheets and paper files.
It may seem like a lot, but it breaks down into clear steps. Here is the typical path — and where SHEQhub takes the heavy lifting off your plate:
SHEQhub runs on all internet-enabled devices. Manage your quality system from anywhere, at any time.
Store all your QMS documents in a central cloud-based location. Share documents between relevant parties and maintain full version control.
Streamline document sign-offs with email notifications, request management, and exception escalation for timely action.
Design easy-to-use forms that can be filled out on any device. Save drafts and allow multiple users to collaborate on the same form.
Keep a real-time overview of your compliance activities with system dashboards that track progress and highlight issues.
Schedule regular inspections and checklists with automated email reminders to responsible staff when tasks are due.
Document owners are notified of upcoming annual reviews, change requests, and any action items requiring attention.
Conduct internal audits or allow external parties such as your ISO certification body to audit directly through the platform.
Track non-conformances and corrective actions with full activity logging. Items not actioned within defined timeframes are automatically escalated.
User-defined review processes with full revision history, distribution management, and verification of reviewed documents.
Whether you have an in-house team, your own consultant, or need us to connect you with one — SHEQhub has a solution that fits your company. Sign up for free to explore the platform, or get in touch and we’ll help you find the right option for your situation.