Audit-ready in 90 days. Stay that way every day after.
Built for medical device distributors and ISO 13485 manufacturers who need to pass regulatory inspection, hold the licence, and run the regulated business — without a quality system that leaves with the consultant, and without breaking their team’s brain.
Audit-ready means every SAHPRA-Ready Mode criterion is green. It is our readiness standard, not a SAHPRA or certification-body decision.
Already know you want the platform? See plans and pricing →
- Free · 27 questions · about 4 minutes
- Your gaps ranked by risk, each mapped to its ISO 13485 clause
- No card
Built for licensed medical device distributors and ISO 13485 manufacturers. African-built, international-grade.
We’re not audit-prep software. We’re the operating system you actually run on.
Audit-prep software ships its customer on the day they pass audit. We don’t. The platform is built to take you from zero documentation to audit-ready in 90 days, and then to run the regulated calendar on your behalf every day after.
The roadmap, not the checklist.
We turn ISO 13485 and your medical device regulator's guidelines into a ranked list of next actions your team can actually do. No 77-clause spreadsheet. No consultant-speak.
The calendar runs itself.
Management Reviews, Internal Audits, supplier re-evaluations, licence renewals, Vigilance reporting — every regulator-imposed deadline is auto-scheduled the moment your scope is set.
Plain English, every screen.
Built for the Quality Manager who has never used compliance software, not for the QA expert who already has. If your mother could not read a sentence, it does not ship.
Templates that look like real SOPs.
Thirteen audit-grade Standard Operating Procedures, written for medical device distributors and ISO 13485 manufacturers, edit-ready in markdown. No blank canvas. No "good luck out there".
Audit prep is the door. The OS is the room.
Audit-readiness in 90 days gets you in. Staying audit-ready every day after is what the platform is actually for — and what a consultant who packs up and leaves was never going to do.
Tamper-evident, regulator-respectful.
Record changes go into an append-only, SHA-256 hash-chained audit log you can verify from the admin console. Built with POPIA in mind. Regulator-friendly by intent — we help you comply, never to outsmart the regulator.
One platform, your regulator.
ISO 13485 is universal — your regulator is not. Each regulator (SAHPRA in South Africa, the EDE in the UAE, more to come) loads as a configurable rule-set, not hard-coded logic. Expand into a new market without switching tools.
Built for every licensed medical device business
If you hold a medical device establishment licence or an ISO 13485 certificate (or you should), the platform is built for you.
- Licensed medical device distributors
- ISO 13485 medical device manufacturers
- Medical device importers and wholesalers
- Refurbishers and own-label re-packagers
- Pan-African distributors expanding cross-border
- Regulatory consultants managing multiple clients
One monthly fee. The system stays when the consultant leaves.
Every tier replaces the consultant who leaves and takes the system with them — and runs the regulated calendar for you 365 days a year. Pick the tier that fits where you are today.
Starter
Founding rate — 30% off while you stay · 10 of 10 left
For the smallest distributors and single-Responsible-Pharmacist outfits getting ready for their ISO 13485 audit.
- 1 organisation, 1 user
- Continuous QMS readiness score + Fix Queue
- Document vault, e-signature approvals + SOP template library
- Licence & certificate renewal sentinel with reminders
- Supplier register (up to 20 suppliers)
- SAHPRA regulatory feed (read)
- Audit pack export
- Email support
Growth
Founding rate — 30% off while you stay · 10 of 10 left
For the typical licensed distributor or ISO 13485 manufacturer. The pricing sweet spot.
- Up to 5 users
- Everything in Starter
- Regulatory feed impact assessments → auto-created deadlines
- Vigilance and post-market surveillance module
- Unlimited supplier register
- Mock SAHPRA inspection / ISO 13485 audit simulator
- Google Drive document connector
- Monthly readiness report to your inbox
- Priority support
Scale
For distributor groups, importers with multiple licences, and manufacturers with more than one site.
- Unlimited users
- Everything in Growth
- Multiple organisations under one login (consultant / group view)
- Auditor access portal for external audits
- Day-One QMS build: a tailored, complete document set generated with you
- Quarterly readiness review with our regulatory team
- Next-business-day answers on regulatory questions
Enterprise
For manufacturers, large national distributor groups, and multinationals expanding into Africa.
- Everything in Scale
- Dedicated customer success manager
- Quarterly on-site QMS review
- Custom integrations (ERP, legacy e-QMS) scoped and built for you
- Annual independent ISO 13485 readiness assessment (included)
All tiers billed in South African Rand. We are not registered for VAT, so no VAT is added to these prices. Choose a 12-month agreement (billed monthly or annually), a 3-year plan, or month-to-month. Pay annually for two months free and no setup fee, and our first 10 paying customers keep a 30% founding rate on a 12-month or longer plan for as long as they stay, with no setup fee. Setup fees, and what setup includes, are on the pricing page.
Currently quoted a fortune for audit prep?
That’s the door. Nobody quoted you what happens after — because audit-readiness is a state you have to maintain every day, with deadlines that never stop coming. The compliance OS replaces the consulting project and the ongoing pain, on one predictable monthly fee.
Get in touch
Email hello@iso13485-compliance.co.za or start with your free Gap Heatmap. We’re based in Cape Town.