Version 1.5 · Amended 20 October 2026 · Drafted 23 September 2026 and revised 27 September 2026. Version 1.0 was reviewed and approved on 1 October 2026 and took effect that day. Version 1.1 (7 October 2026) waived the setup fee for founding customers on the Monthly plan (§4 and §4.B). Version 1.2 withdraws the readiness guarantee (§4.2) and states in §4 that no VAT is charged. It applies to subscriptions whose first paid term begins after it is published, and to existing accounts from their next login or renewal, whichever is first, subject to §4.2. Version 1.3 (11 October 2026) adds the CE Mark & Global Markets add-on (§4.4), the CE Pack Review (§4.5), introductions to third parties (§4.6), the EU and other-market roles in §1, and clinical data in §7, and extends the liability limit in §8 to all fees paid, not only subscription fees. Its new sections apply when you take up those offers; the change to §8 only increases what we can be liable for, so it applies to every customer from publication. Version 1.4 (18 October 2026) adds §4.2A, the refund rules for the Inspection-Ready Kit and Jumpstart, which match what the funnel already offered. Version 1.5 (20 October 2026) ends the free trial for new organisations (§4 and §4.1): trial access now comes with the Jumpstart, or where we grant it. An organisation already on a trial when version 1.5 is published keeps it until it ends.

Terms of Service

These terms govern use of the ISO-13485 Compliance OS platform (“the Platform”, “we”, “us”) by any organisation or individual (“you”, “Customer”) that registers for or uses it. By creating an account you agree to these terms and to our Privacy Notice.

1. What the Platform is — and is not

The Platform is a compliance-operations tool that helps organisations organise evidence, track obligations, and manage a quality management system aligned to ISO 13485:2016. It is decision-support software, not legal or regulatory advice. We are not a regulator, not a conformity assessment body, and not the South African Health Products Regulatory Authority (SAHPRA). Nothing in the Platform, and nothing we say to you, implies SAHPRA endorsement, pre-approval, or certification of your organisation or your submission. SAHPRA remains the sole regulator of medical devices in South Africa, and ISO 13485 certification is issued only by an accredited conformity assessment body — not by us.

The same applies to the European Union and the other markets the Platform covers. We are not a notified body, an EU authorised representative, an importer, a person responsible for regulatory compliance (PRRC), a Swiss authorised representative, a UK Responsible Person, or a local agent or representative in any market, and we do not take on any obligation the EU Medical Device Regulation (EU) 2017/745 or any other law places on a manufacturer or on those parties. Only a notified body issues an EU certificate, and only you, as manufacturer, may sign an EU Declaration of Conformity and affix the CE marking. Device classifications, readiness scores and market information in the Platform are indicative, based on the information you give us and on the law as we understand it when we publish it. Rules change, and local requirements in other markets should be confirmed with your local representative or adviser.

You remain solely responsible for validating that the Platform is fit for its intended use within your quality management system, as required by ISO 13485:2016 Clause 4.1.6 (validation of the application of computer software). A vendor software-validation documentation pack is available on request to support that exercise — it is evidence for your validation file, not a substitute for you performing it.

2. AI-assisted features

Certain features (gap analysis, document classification, SOP-drafting assistance, training-quiz generation, regulatory-feed processing, and the review of CE and MDR documents you upload) are AI-assisted, using a third-party large language model provider. Their output is advisory only — it may be incomplete, wrong, or miss context a qualified person would catch — and must be reviewed by a qualified person in your organisation before you rely on it for any compliance, regulatory, or business decision. See our Privacy Notice for what is sent to that provider and when.

3. Accounts and organisations

You must provide accurate registration information and keep your login credentials confidential. You are responsible for activity under your account and for the accuracy of data your organisation’s users enter into the Platform. Each organisation’s data is isolated from every other organisation’s data.

4. Subscriptions, trial access and billing

We do not offer a free trial. Access starts when you buy a plan on our pricing page, or with the trial access described in §4.1. Paid subscriptions are billed in South African Rand and processed by Paystack, our third-party payment processor — we do not receive or store your full card details ourselves. Payments are collected on our behalf by Batho Pele Group (Pty) Ltd, so your bank statement and Paystack receipt show that name. Where the pricing page for your market shows prices in another currency (for example US dollars), you are billed in the currency shown at checkout or on your order confirmation. Fees and plan tiers are as published on the pricing page on the day you subscribe. We are not registered for VAT, so no VAT is included in or added to our prices. If we register, VAT is added only under the price-change rule below: from your next renewal, never during an agreement term you have already entered. The once-off Inspection-Ready Kit and Inspection-Ready Jumpstart sold through our funnel are different: they are sold by Batho Pele Group (Pty) Ltd (VAT reg. no. 4100275900), their prices include 15% VAT, and a tax invoice is available on request. You choose one of these plans:

• Annual — a 12-month agreement, paid yearly in advance. No setup fee.
• Monthly — a 12-month agreement, paid monthly, plus the once-off Audit-Ready Setup fee in §4.A with your first payment. While founding places remain, a first-time subscriber on the Monthly plan has this fee waived and still receives the Audit-Ready Setup (§4.B).
• 3-year certification cycle — a 36-month agreement, paid yearly in advance at 15% below the Annual price. No setup fee.
• Flex — month to month with no agreement term, at 20% above the Monthly price, plus the setup fee. While founding places remain, a first-time subscriber can instead take Flex at the Monthly price with no setup fee; that plan does not include the Audit-Ready Setup in §4.A.

Checkout shows your agreement term, your recurring price and your first charge before you pay. We may change our prices on at least 30 days’ notice. A change never applies during an agreement term you have already entered, or to a period you have already paid for; it applies from your next renewal.

4.A Audit-Ready Setup

The setup fee (R9,950 Starter, R24,950 Growth) pays for setting your organisation up in the Platform, once:

• a 60-minute guided setup session with us;
• your starting QMS generated from the full procedure library, matched to your SAHPRA licence activities;
• up to 25 of your existing documents brought under document control;
• your approvers, roles and document review cycle configured; and
• your management-review and internal-audit cadence scheduled, with your team invited.

It is not charged again if you re-subscribe within 90 days of your service ending, unless your service ended during an agreement term (other than by our breach), or your earlier plan did not include the Audit-Ready Setup. Otherwise it is charged again, because your organisation has to be set up again.

4.B Founding rate

If you subscribe while founding places remain, you receive the founding discount shown on the pricing page for as long as your subscription continues without a break. It ends if your subscription ends; a later subscription is charged at the price then in force. On a Monthly, Annual or 3-year plan the founding benefit includes the Audit-Ready Setup in §4.A with the setup fee waived. A waived setup fee is treated as paid for the purposes of §4.A, and becomes payable under §5 if you leave before your agreement term ends. On a Flex plan the founding benefit is the Monthly price with no setup fee, not the founding discount, and the Audit-Ready Setup is not included.

4.C Renewal

At the end of an agreement term your subscription continues month to month, or year to year on the Annual and 3-year plans, at the price then in force, unless you cancel. We will remind you in writing between 40 and 80 business days before a 12- or 36-month term ends, and tell you what happens if you do nothing.

4.1 Trial access

Trial access is a fixed period of use with no subscription: the 30 days of full access included with the Inspection-Ready Jumpstart, or a period we grant you in writing. It ends on the date shown in your workspace, and your workspace then switches to read-only until you subscribe; nothing is deleted. The trial is intended to let you diagnose where you stand, not to deliver a finished quality management system. During the trial you have full use of the assessment features — gap analysis, readiness scoring, the SAHPRA obligation map and your own uploaded evidence — and you may export your assessment results. Documents produced from our template library during a trial, or after a subscription has lapsed or been cancelled, are issued as uncontrolled copies: they are watermarked as such, they are not under document control, they carry no approval, revision or distribution record, and they are not suitable for regulatory submission or for presentation to an auditor. Bringing a document under control is a paid feature.

4.2 No money-back guarantee

We do not offer a money-back guarantee. The free Gap Heatmap on our website is there so you can see where your organisation stands before you pay. Fees are refundable only as §4.2A sets out for the Kit and Jumpstart, as §4.3 sets out for done-for-you engagements, or where the law requires it. A subscription whose first paid term began before version 1.2 of these terms took effect keeps the readiness guarantee for that first term, on the conditions in version 1.1 of these terms. We send a copy of those conditions on request to hello@iso13485-compliance.co.za.

4.2A Inspection-Ready Kit and Jumpstart

You can cancel the Inspection-Ready Jumpstart for a full refund at any time before your session takes place. Email hello@iso13485-compliance.co.za with your payment reference and we process the refund to the card you paid with within 5 business days; your bank may take longer to show it. Once the session has taken place, the Jumpstart is not refundable. The Inspection-Ready Kit is a digital download and is not refundable once we have sent it to you. If you have paid and we cannot deliver either one, we refund you in full. If you subscribe within 30 days of buying the Jumpstart, its price comes off your first month. Your rights under the Consumer Protection Act and the Electronic Communications and Transactions Act are not affected.

4.3 Accelerator and other done-for-you engagements

Accelerator, consulting and done-for-you document work are services, not part of your Platform subscription. Each engagement is governed by a separate written statement of work that sets out its scope, its milestones, the fees for each milestone and the deposit payable on signature. These terms apply to that engagement except where the statement of work says otherwise.

• Fees are billed as a deposit on signature and the balance against milestones as each is delivered. Fees for a milestone already delivered are not refundable.
• Where we commit to keep working at our cost if you are not audit-ready by an agreed date, that commitment is to continue the agreed scope of work — it is not a refund, it does not extend to new scope, and it does not cover third-party costs such as conformity assessment body fees, regulator fees or travel.
• “Audit-ready” means the written readiness criteria recorded in the statement of work at kick-off. We do not work to an unrecorded standard, and neither of us should have to argue afterwards about what was meant.
• That commitment assumes you have met your own obligations: supplying the information, documents and approvals we request within the times set in the statement of work, making your nominated responsible person available, and attending the scheduled sessions. Delay caused by you, by a regulator or by a conformity assessment body moves the agreed date day for day.
• The commitment runs until the recorded readiness criteria are met or for a further 60 days from the agreed date, whichever comes first. We will tell you in writing when it ends.
• We cannot and do not guarantee any inspection, licensing or certification outcome. Those decisions belong to SAHPRA and to conformity assessment bodies, not to us.

4.4 CE Mark & Global Markets add-on

The add-on is an addition to a paid subscription, not a plan on its own, and follows that subscription’s billing period, renewal and cancellation (§4.C and §5). It covers the number of devices shown on the pricing page when you take it up; a device means one device or device family under one Basic UDI-DI. Further devices are charged at the published per-device price from the month they are added. The add-on gives you the CE Mark workspace in the Platform: device classification, the technical-documentation checklist, the review of documents you upload, target-market steps, draft documents and deadline reminders.

• The checklist, classification, market steps and draft documents are tools to help you prepare. They do not establish that your device or your documentation conforms to any law, and a readiness score is our measure of the items you have marked complete, not a notified body’s or regulator’s view.
• A draft EU Declaration of Conformity is a starting text. It is complete and correct only when you have completed and checked it, and signing it is your act as manufacturer.
• We keep the regulatory content under review and update it when we become aware of a change, but we do not undertake to do so by any particular date. Deadlines in the Platform are reminders; meeting your legal deadlines remains your responsibility.

4.5 CE Pack Review

The CE Pack Review is a one-off service for one device. You give us your existing CE or MDR documentation (up to 30 documents) and we give you: the documents mapped against the MDR checklist for the device’s indicative class, the items we find covered, partly covered, missing or out of date, a readiness score, a prioritised list of what to fix, and a call of up to 30 minutes to go through them. The fee is the one shown on the pricing page or in our written order confirmation, payable before the review starts, and is not refundable once we have delivered the findings, except where the law requires it.

• The review is a desk review of the documents you supply, partly AI-assisted (§2) and checked by us. It is not an audit, a notified body assessment, a legal opinion, or a verification of test results, clinical data or anything outside the documents.
• Its findings depend on what you give us. Documents you leave out, or information that is wrong or out of date, will not be reflected in them.
• Work beyond that scope, such as fixing what the review finds, is a separate engagement under §4.3.

4.6 Introductions to third parties

If we introduce you to a third party, such as an EU authorised representative, a notified body, a clinical writer or a test laboratory, you contract with them directly and on their terms. They are not our agents or subcontractors, we do not supervise their work, and we are not responsible for their services, fees or decisions. If we receive a fee or other benefit for an introduction, we tell you before you engage them.

5. Cancellation

You cancel in the Platform’s billing settings, or by writing to us.

• Flex, or after an agreement term has ended: cancellation takes effect at the end of the period you have paid for.
• During an agreement term: by default your cancellation is scheduled for the end of the term. Your service continues until then, and so do monthly payments on the Monthly plan. Nothing renews after that date.
• Leaving before the term ends: you may end the agreement early on 20 business days’ written notice. You then pay an early-termination charge equal to the discount you received compared with the Flex price, plus the setup fee if it was waived — in effect, what you would have paid on Flex from the start. It is never more than the fees that would otherwise have remained for the term.
• Payments already made are not refunded pro rata, except where the law requires it.

When your service ends, your data stays available read-only for 12 months so you can export it or come back, and is then deleted in line with the retention schedule in our Privacy Notice; ask us and we will delete it sooner. You remain responsible for your own regulatory record-keeping: ISO 13485 and SAHPRA require you to retain your quality records, and the Platform is not your system of record of last resort.

6. Acceptable use

You agree not to:

• Use the Platform to store or process personal information you are not lawfully entitled to hold;
• Attempt to access another organisation’s data, bypass tenant isolation, or probe the Platform’s security;
• Use the Platform, or the documents it produces, to misrepresent your organisation’s ISO 13485 or SAHPRA status, or the CE marking or regulatory status of any device;
• Resell or provide the Platform to third parties outside your own organisation without our written agreement;
• Introduce malicious code, or interfere with the Platform’s availability to other customers.

7. Your data

You own the data your organisation enters into the Platform. We process it to provide the service, as described in our Privacy Notice, and you can export it at any time.

Clinical and patient data. Clinical evidence you upload, for example to a clinical evaluation report or for a CE Pack Review, should be aggregated or anonymised. Do not upload information that identifies a patient or trial participant unless we have first agreed in writing how it will be processed, including any data processing terms the EU General Data Protection Regulation or POPIA requires. You are responsible for having a lawful basis for any personal information you upload.

Our content. The Platform, its template library, its assessment logic, its scoring rules and its regulatory mappings remain ours. While your subscription is in good standing we grant you a non-exclusive, non-transferable licence to use the documents you generate from our template library for your own organisation’s internal quality management and regulatory purposes. That licence does not let you resell, publish, distribute or license those documents outside your organisation, use them to provide a competing or consulting service to anyone else, or use them to train a machine-learning model. Documents you have generated remain licensed to you for your own internal use after you cancel, but we no longer maintain, update or control them, and copies exported outside a paid subscription are uncontrolled copies as described in §4.1.

8. Disclaimers and limitation of liability

The Platform is provided on an “as is” and “as available” basis. To the maximum extent permitted by South African law, we disclaim all warranties not expressly stated here, including any warranty that the Platform will guarantee SAHPRA approval, ISO 13485 certification, or any particular audit or inspection outcome. Our total liability to you arising out of or in connection with these terms is limited as set out in the box below.

9. Suspension and termination

We may suspend or terminate your access if you materially breach these terms and do not remedy the breach within 14 days of written notice from us. Where the breach is of the security or tenant-isolation provisions of §6, or where continued access poses an immediate risk to other customers or to personal information we hold, we may suspend access immediately and give you notice as soon as is practicable afterwards.

10. Governing law

These terms are governed by the laws of the Republic of South Africa, and the courts of South Africa have jurisdiction over any dispute arising from them. Before either of us litigates, we each agree to give the other written notice of the dispute and to try in good faith to resolve it within 10 business days. That does not stop either of us from applying urgently to a court for interim relief. For a specific claim that falls within its monetary jurisdiction, and once that claim exists, we may agree between us to have it heard in the Magistrate’s Court rather than the High Court, so that a small dispute does not carry High Court costs; absent that agreement at the time, jurisdiction follows the ordinary rules.

11. Changes to these terms

We will update the version number and effective date at the top of this page whenever these terms change materially, and will give existing customers at least 30 days’ notice by email before a material change takes effect. If you do not accept a material change, you may cancel under §5 before it takes effect.

12. Contact

Questions about these terms: hello@iso13485-compliance.co.za. Registered details: COMPLYOS (Pty) Ltd, registration number 2026/365192/07, of 17 Orbea Close, Kronenzicht, Cape Town, 7806.