Pricing
Enterprise-grade compliance.
Priced so you can actually buy it.
Most enterprise QMS platforms charge in dollars and assume you have a procurement team. We don’t. Start with the free Gap Heatmap: 27 questions, about 4 minutes, so you see where you stand before you pay anything.
We are not registered for VAT, so no VAT is added to these prices. Prices are in South African Rand. Full terms.
Founding customer pricing — 10 of 10 left
Lock in 30% off for as long as you stay subscribed on a 12-month or annual plan if you're one of our first ten customers, with custom onboarding included and no setup fee. Reference logo on our site and a direct line to the founder.
12-month agreement. While founding places last, founding customers pay no setup fee and the guided Audit-Ready Setup is included. After that it is a once-off R 9,950 Starter · R 24,950 Growth, waived when you pay annually.
Starter
For the smallest distributors and single-Responsible-Pharmacist outfits getting ready for their ISO 13485 audit.
Founding rate · 10 of 10 left30% off while you stay subscribed
Choose Starter- 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
For the typical licensed distributor or ISO 13485 manufacturer. The pricing sweet spot.
Founding rate · 10 of 10 left30% off while you stay subscribed
Choose Growth- 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.
Quoted on a call — set up with you, invoiced
Talk to us- 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.
Quoted on a call — set up with you, invoiced
Talk to us- 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)
Selling into Europe or other CE markets?
Your ISO 13485 system is half of a CE mark under the EU MDR. Add the other half. Free CE readiness check.
CE Mark & Global Markets
Get the CE mark, then keep it, in every market it opens.
- ✓Up to 3 devices, each classified under MDR Annex VIII
- ✓Technical-file checklist with a ready-for-the-notified-body score
- ✓Upload and review of your existing CE / MDR pack
- ✓Draft EU Declaration of Conformity and technical file index
- ✓Every target market's local steps: Switzerland, UK, Turkey, Saudi Arabia, UAE, Australia and more
- ✓PSUR, PMS and vigilance deadlines that keep the CE mark current
CE Pack Review
Already have a CE or MDR pack? Find out where it stands.
- ✓Your existing CE / MDR pack reviewed against the MDR checklist for your device class
- ✓What is covered, what is missing, and what is out of date (MDD, old standards)
- ✓Your ready-for-the-notified-body score and a prioritised fix list
- ✓A 30-minute call to walk through the findings
Excludes applicable taxes. Notified body, authorised representative and testing fees are charged by those parties, not by us. We help you prepare; certification decisions belong to your notified body.
Need this done, not explained?
Compliance Acceleration Program — from R120,000
Done-for-you compliance: platform + regulatory advisory + implementation. Audit-ready in 90 days or we keep working at our cost.
Audit-ready means every SAHPRA-Ready Mode criterion is green and our mock inspection is closed. It is our readiness standard, not a SAHPRA or certification-body decision, and we cannot guarantee any inspection or certification outcome.
What you'd pay for the alternatives
Most options are priced for US/EU mid-market manufacturers. The forex alone is brutal. We're built for the same regulatory reality but priced for it too.
| Platform | Typical annual cost | In ZAR (R18.50/USD) |
|---|---|---|
| MasterControl | $80,000–$150,000 | R1.5M–R2.8M |
| Veeva Vault QMS | $50,000–$200,000 | R925K–R3.7M |
| Greenlight Guru | $30,000–$60,000 | R555K–R1.1M |
| Qualio | $12,000–$36,000 | R220K–R670K |
| ISO-13485 Compliance OS · Growth | ~$9,700 | R179,940 |
Public pricing pulled from vendor disclosures and industry reports. Verify with each vendor — most hide it behind sales calls.
Built for real companies under real regulatory pressure
Compliance software is a trust purchase. Here is who stands behind the platform and how your data is handled — before you ask.
Used in production by a related company
Built alongside a SAHPRA-licensed medical device distributor in our founder’s group of companies, which is putting its own ISO 13485 quality system in place on the platform. That is a related party, not an independent customer. We use it against a real regulatory scope, and we will show you which modules that covers.
Your data, your export
Download your audit pack as one ZIP — a summary report, your clauses, findings, CAPAs, internal audits and document register as CSV, plus the evidence files themselves — and export module data to CSV. No lock-in. Production data is encrypted at rest; every session is TLS.
A registered South African company
Operated by COMPLYOS (Pty) Ltd (reg. no. 2026/365192/07), based in Cape Town — not a side project. The compliance audit log is tamper-evident by design, so your regulatory chain of custody survives a vendor change either way.
Where your data lives
Your database, sign-in and evidence files are hosted by Supabase in the EU (Ireland); the web application runs on Netlify, with server functions in the United States. Both providers hold SOC 2 reports. Every sub-processor is listed in our Privacy Notice.
Common questions
Which regulators do you support?
The platform is built around ISO 13485:2016 — that's universal — with a configurable regulator layer on top: a regulator's licences, submission formats and deadline rules load as a rule-set rather than being hard-coded. SAHPRA is live today; UAE (EDE) support is planned. If you sell into multiple regions, talk to us — we prioritise the regulators our customers actually need.
How do I start?
Take the free Gap Heatmap first. It ranks your biggest gaps across nine ISO 13485 areas in about 4 minutes, and the results show your next step. Already know you want the platform? Pick a plan above: you create your account, pay by card through Paystack in rand, and it unlocks as soon as the payment clears.
How do the plans and terms work?
Standard plans are a 12-month agreement billed monthly, with a once-off Audit-Ready Setup fee (R9,950 Starter, R24,950 Growth): a 60-minute guided setup session, your starting QMS generated to match your licence, up to 25 of your existing documents brought under control, approvers and review cycles configured, and your management-review and audit cadence scheduled. Pay annually and the setup fee is waived and you get two months free. While founding places are open, founding customers on a 12-month, annual or 3-year plan pay no setup fee, however they pay: the guided setup is included. A 3-year plan, matching your certification cycle, is 15% off and billed annually. Prefer no commitment? While founding places are open, month-to-month is the standard monthly price with no setup fee, and you can cancel any time. You set up the platform yourself; the guided Audit-Ready Setup is not included, and you can add it later by moving to a 12-month, annual or 3-year plan. After the founding places are gone, month-to-month is 20% more, with the setup fee. Founding rates apply for as long as you stay subscribed. If you cancel and return within 90 days, there's no setup fee, unless your earlier plan didn't include the setup.
Is my data really mine?
Yes. You can download your audit pack as one ZIP — summary report, clauses, findings, CAPAs, internal audits and document register as CSV, plus the evidence files — and export module data to CSV. Your data is never locked in; it's how we'd want to be treated.
What if my company already has a QMS in SharePoint / Excel / another tool?
Most medical device businesses do. We help with data migration when you come aboard — we'll bring your existing SOP register, gap register, and audit findings across before you go live. No hand-rebuild.
Are you ISO 27001 / SOC 2 certified yourselves?
Not yet — we don't hold ISO 27001 or SOC 2 ourselves, and we won't claim to. We're built on Supabase (SOC 2 Type II) and Netlify (SOC 2). Production data is encrypted at rest, all sessions are TLS, and our audit log captures every state-changing action — the tamper-evident regulatory chain of custody you'll want at any regulator's inspection.
Can quality consultants and auditors get a partner tier?
Yes — Enterprise tier supports unlimited orgs under one consultant account. If you're a regulatory consultancy serving multiple medtech clients, ping us for partner pricing. We're actively building the consultant side of the market.
Start with your top 3 gaps. Free.
27 questions, about 4 minutes. Your gaps come back ranked by risk, each mapped to its ISO 13485 clause.
Find your top 3 gaps, free