Your quality system was the start, not the whole job

ISO 13485 or FDA design controls get the device to market. What comes next, the security questionnaires, the patient-data obligations, the AI Act, rarely fits the eQMS. Wizard sits alongside the quality system you already run and holds all of it in one auditable place, or stands up the whole system with you if you are starting without one, IEC 62304 software processes and ISO 14971 risk management included.

The gaps open up around the quality system, not inside it

Your eQMS does its job. It holds ISO 13485 or your FDA design controls, the design history file and the risk management file. The trouble starts at its edges. A hospital sends a security questionnaire. GDPR applies because you process patient data. The AI Act applies because there is a model in the product. A US buyer asks about your FDA submission and your cybersecurity documentation. None of it fits the eQMS, so it lands in spreadsheets and shared drives, owned by whoever picked it up last.

Then something changes, a supplier, a sub-processor, a new integration, and the quality system moves on while the rest stays where it was. When an auditor, a notified body or a buyer's security team asks for it, preparation becomes archaeology, working backwards from the current product to a paper trail that explains how you got here.

An eQMS covers ISO 13485 and stops there

The scope outgrows the system. Your eQMS handles documents, CAPAs and training properly. Then a hospital sends a security questionnaire, or GDPR applies because you process patient data, or the AI Act applies because there is a model in the product. None of it fits, so it goes into spreadsheets alongside the controlled system.

Compliance sits outside where work happens. Engineering works in one set of tools, quality in another, and every change needs someone to notice it and carry it across. That handoff is where traceability is lost.

Everything is built around the assessment. Systems designed for certification produce a burst of activity before an audit and quiet decay after it. That holds until the product changes faster than the documentation can follow.

One system that holds the whole picture, alongside your eQMS or in place of it

Two ways in. Connect Wizard to the quality system you already run and let it hold everything around it, or stand up the full system in Wizard from the start. Either way, one place and one source of truth.

Configured to how you work. Your consultants and your own QA and RA people set Wizard up to your requirements, so it follows your methodology and builds in best practice rather than forcing a fixed template on you.

One thread across every framework. Requirements, risks, controls and evidence reference each other, so a single control shows every obligation it serves at once, ISO 13485, IEC 62304, ISO 14971, security, privacy and the AI Act. Change one and the items attached to it surface straight away. PLACEHOLDER: product screenshot, linked registers view.

Change carries its consequences. Any change to a document, risk or control triggers the review path attached to it, with owners named and dates recorded. Version history is a by-product of the work. PLACEHOLDER: product screenshot, document control with version history.

Framework-agnostic as the scope grows. ISO 13485 or FDA design controls today, ISO 27001 when a client asks, GDPR for patient data, the AI Act if there is a model in the product. A new standard extends the system rather than starting another one. PLACEHOLDER: product screenshot, multiple frameworks in one workspace.

Audit readiness as a state. Evidence is created as work happens, so producing an audit pack, for a notified body, an FDA reviewer or a client's security team, means filtering what is already there. PLACEHOLDER: product screenshot, audit and evidence view.

Where Wizard fits, and where it does not

Against a dedicated eQMS. If ISO 13485 is your entire compliance scope and it is likely to stay that way, a dedicated eQMS will serve you well and you should keep it. Wizard becomes the better choice when the scope has already grown beyond one standard and you are maintaining a second, uncontrolled system alongside the first.

Against automated compliance platforms. Tools built around ISO 27001 and SOC 2 automate evidence collection from cloud infrastructure very effectively. They are not built for design controls, risk management files or technical documentation, so a medical device company usually ends up running one of those and an eQMS in parallel. Wizard is built to hold both.

Against spreadsheets and shared drives. They work until they do not, and the moment they stop working is usually the week before an assessment. If that is where you are, the honest first step is the Compliance Health Check rather than a demo.

What Wizard is not. It is not a regulatory consultancy. Deciding your classification, writing your clinical evaluation or preparing your submission is not what this is. And it will not make you compliant automatically. No platform does. It makes the work visible, owned and current.

Built by people who have been audited, and who have audited others

Wizard was designed by people who spent years building these systems inside regulated organisations before they built software for them. What follows is their professional background. These were consultancy and audit engagements, not Wizard implementations, and we mention them because the design decisions in this product came directly from that work. Read more about the team.

Eoghan Kenny, Co-Founder and CEO. Over twenty years implementing governance, risk and compliance systems in regulated organisations. He has built integrated management systems covering ISO 27001, and implemented a live eQMS compliant with ISO 13485 and IEC 62304 at Amara Therapeutics. He has also worked as an external Data Protection Officer for organisations processing special category data.

Derek Mizak, Co-Founder and CTO. Over thirty years across cybersecurity, audit and systems architecture. He has audited management systems as a certification body auditor for Certification Europe (now Amtivo), which means he has seen what auditors actually open first and which parts of a quality system look complete until someone pulls on them.

Dominic O'Toole, Co-Founder and CPO. Over twenty years building enterprise software, including at IBM and Fidelity.

Common questions

We already have an eQMS. Why change?

You may not need to. If ISO 13485 or your FDA design controls are your whole compliance world and likely to stay that way, keep the eQMS you have. Wizard is for everything that sits around it, the security, privacy and AI obligations that do not fit the quality system, and it connects to the eQMS you already run rather than replacing it. If you would rather run the lot in one place, it can do that too.

Does Wizard support ISO 13485 out of the box?

Not as a prebuilt template, and that is deliberate for now. Wizard is configured to ISO 13485 for each client, set up by your consultants and your own QA and RA people to your requirements, with best practice built in. The system follows your methodology rather than bending you to a fixed template. A prebuilt ISO 13485 starting point is on the roadmap.

How long does implementation take?

[PLACEHOLDER: to confirm. A real range, and what it depends on.]

Where is our data held?

Microsoft Azure, with enterprise-grade access controls. Our sub-processor list and data processing agreement are published on the site.

Are you certified to ISO 27001 yourselves?

Wizard is built to ISO 27001 requirements and hosted on Microsoft Azure in Ireland, with our security architecture, Data Processing Agreement and sub-processor list published on our Legal, Privacy and Security page.

What does it cost?

Standard plans start at 600 euro per month billed annually for up to 30 active users. Consultant accounts are free and do not count toward the limit.

See it against your own quality system

Request a demo and we will walk through how this works for your product and your standards. If you would rather see where you stand first, the Health Check takes five minutes. Request a demo.