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 an expensive consultant and without breaking their team’s brain.
Used by 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 your consultant was never going to do for R250,000.
Tamper-evident, regulator-respectful.
Every action logged with SHA-256 hash chaining. Privacy-compliant by design. 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
Pricing
Every tier replaces a R250,000 consultant — and runs the regulated calendar for you 365 days a year. Pick the tier that fits where you are today.
Starter
For the smallest distributors and single-Responsible-Pharmacist outfits getting to audit-ready.
- 1 organisation, 1 user
- Continuous QMS health monitoring
- Document vault + SOP template library
- Annual surveillance audit pack
- Read-only regulatory feed
- Email support
Growth
For the typical licensed distributor or ISO 13485 manufacturer. The pricing sweet spot.
- Up to 5 users
- Everything in Starter
- Full regulatory feed with auto-classification
- Vigilance and post-market surveillance module
- Supplier re-qualification (up to 20 suppliers)
- Mock regulatory inspection simulator
- Slack / Teams / email integration
- Priority support
Scale
For distributor groups, importers with multiple licences, and manufacturers operating in SA plus abroad.
- Unlimited users
- Everything in Growth
- Unlimited supplier register
- Multi-entity dashboard (group view)
- Multi-jurisdiction regulatory feed (EU MDR, FDA, TGA, MHRA)
- White-label auditor portal
- Quarterly health check with our regulatory team
- 24-hour SLA 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, custom feeds)
- Annual independent ISO 13485 readiness assessment (included)
All tiers billed in South African Rand, monthly, no setup fees. Annual contracts save 15%. Audit-prep onboarding included on every tier — no separate consulting bill.
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, for less than the price of a single consulting day per month.
Get in touch
Email hello@iso13485-compliance.co.za or book a 30-minute walkthrough.