Zero to Hero On-DemandA programme by Prof. Dr. Christian Johner

Build the system that reviews your technical documentation – at your own pace.

For specialists and managers in regulatory affairs and quality management — at medical device and IVD manufacturers.

The live programme “Zero to Hero” is sold out. On-Demand gives you the same content as seven video modules – with assignments, model solutions and the base IP. At the end, you have a working review system for intended purpose and risk management that belongs to you, and the method to extend it to any further review aspect.

You review in minutes what currently takes hours to days — and you can repeat it.
You can judge what a purchased review tool is worth — and extend it with your own review criteria.
Make or Buy: build further review aspects yourself – or get all of them fully worked out.

Prerequisite: Word and copy-paste. You learn everything else here.

Book now — introductory price until 30 Nov →

Starts: Tuesday, 1 December 2026 Sales window: 19 October to 30 November 2026 Price: from €3,490 excl. VAT

20+years of experience

1,000+companies advised

20,000+seminar participants

AI guidelineAuthor of the notified bodies’ guideline

The review workload is rising. The time available is not.

Authorities and notified bodies have upgraded with AI. They find so many nonconformities in technical documentation that entire companies come to a standstill. More and more clients are engaging us at short notice for remediation projects.

On top of that come five difficulties that existed before:

Reviewing a risk management file takes hours to days — and it starts again with every change.
More products, more variants, shorter cycles. The same team — and the most experienced people are retiring.
Buy or build? You don’t know what to base that decision on.
No AI access you are allowed to trust with your documents — and Copilot helps with wording, not with reviewing entire files.
And the quiet suspicion that AI skills will decide how relevant your role is in five years.

None of these issues can be solved by working harder. They are structural — which is why extra effort won’t help. Only a tool that takes over the review work itself will.

Buy, build — or both?

Tools for TD review will come onto the market, and some of them will be good. But none of them knows your products, your processes, your review criteria. Only you do. Anyone who buys a tool therefore has to be able to evaluate it — is it fit for our files? — and to extend it with their own criteria. Otherwise you end up reviewing against someone else’s yardstick.

And yes — standards and regulations apply to everyone. But they contain requirements, not review criteria. “The technical documentation shall include the intended purpose” is a requirement. “Is at least one indication defined for each patient group?” is a review criterion. The work lies in between — which is exactly why every company has its own checklists and work instructions, and why an audit checks against your QM system, not just against regulatory requirements.

The prerequisite is your expertise: you know your products, your files, your QM system. What you still need is the craft of translating that knowledge into reviewable criteria. You need this craft for buying tools just as much as for building them.

This craft no longer requires programming skills. You describe what should be reviewed. Agentic systems write the code and the structured data. Your work comes before and after: defining the review criterion and judging whether the result is right.

Three paths, the same prerequisite.

You can’t buy the ability to build, evaluate and extend a TD review system. You have to develop it. And the good news is: It can be learned. In seven modules. At your own pace.

The proof

What a TD review system finds

We have invested more than a thousand hours in this system — and measured it against real technical documentation.

Since the beginning of the year, it has been running against real technical documentation — from 18 manufacturers, in more than 300 review runs across complete files. It finds hundreds of substantiated nonconformities. That is not a lucky hit but the norm: where a human loses focus after page twenty, a system reviews every line with the same rigour.

And we know the findings are correct. Twelve of these manufacturers cross-checked the results themselves — the very people with the greatest interest in proving a false alarm. Eleven out of twelve could not name a single genuine false alarm. How to make this measurable is the content of module 7.

Sample report of the TD review system for the fictitious product CardioAssist: 30 heuristics in 11 sections, 20 of them nonconforming, broken down by intended purpose and risk analysis — Sample report based on the example file (fictitious product).

11 out of 12 manufacturers cross-checked the results — eleven of them found no genuine false alarm

Two roles nobody can take off your hands

When building

You write the yardstick

We provide review criteria — proven ones, from real projects, and many more in the Buy package. But you decide which of them apply to your products, where the threshold lies and what you add. A yardstick only becomes yours once you approve it.

When reviewing

The responsibility stays with you

The system finds deviations, with the same rigour for every line. The final assessment of these deviations is made by a qualified person — because the responsibility stays with them. No AI takes it over, and no vendor can take it off your hands.

What goes away is the grind. What remains is the assessment — and that is the part you are qualified for.

What you get

Your own TD review system.

At the end of the seven modules, it runs on your computer: the review criteria, data structures and scripts you build belong to your company. For the review step itself, the system uses a commercial AI model — contractually secured. Access is included; afterwards, you extend it or use your company’s own AI contract.

You will have built it for two review aspects: intended purpose and risk management. For each further aspect, you follow the same path again — or you choose the Buy package with all further review aspects.

Seven modules on video.

Each module is a lecture by Christian Johner (30–45 minutes), demonstrated on an example technical documentation: how a review criterion is created, how it becomes a data structure and how the review run starts. Plus an assignment and a self-test. The content comes from the live programme; where needed, Christian Johner re-records and edits it. The videos are available for 12 months.

Lessons-learned videos.

Short videos (approx. 5 minutes each) on the problems participants in the live programme got stuck on most often — and how to solve them.

A model solution for every module.

If you get stuck on an assignment, you pick up again with the Lego assembled up to that point — instead of dropping out.

The zero phase.

Basic videos and self-tests, unlocked on 1 December 2026 together with module 1 — so that you start well even from scratch. This is also where you set up your computer.

AI access is included — and you work in it agentically.

IP-protected, in an administered environment: no training on your data, the rights to the results belong to your company. You describe the goal, the agentic tool writes and runs the scripts, you check and correct.

Included is Claude Standard for 4 months, from 1 December 2026 to 31 March 2027. The access is for working on the course content and can be extended.

The base IP — your starting point instead of a blank page.

Review criteria, data structures and scripts for intended purpose and risk management, proven in real projects, plus the example file of a fictitious medical device. Your task is to tailor this material to your products and your review criteria — not to invent it from scratch.

Certificate of attendance and e-mail support.

Once you have completed all seven self-tests, you receive a certificate of attendance. We answer questions about the process and the technology by e-mail within two working days.

Is On-Demand right for you?

This is for you if …

you want to take responsibility and pick up the pace — instead of waiting for someone to bring a tool.
you work for a medical device or IVD manufacturer — in RA, QM, approvals, development, clinical affairs or as a PRRC.
you review, are responsible for or create technical documentation.
you prefer to learn at your own pace rather than on fixed dates — and can set aside around 2–3 hours a week.
you want to end up with something of your own that lasts — your review criteria, your scripts, no third-party tool.
you want to evaluate a purchased tool and extend it with your own review criteria.
you are starting from zero. If you work with Word and can copy text, you will learn everything else here.

This is not for you if …

you believe you can keep working over the next few years the way you did over the last twenty.
you are looking for finished software you just switch on. No vendor can supply the yardstick for the review — and no vendor can take the responsibility for the result off your hands.
you need personal support or direct exchange with Christian Johner. On-Demand does not offer that.
you do not come from the medical device world. The programme works throughout on the example technical documentation of a medical device.

Your result after seven modules

Today	After seven modules
Reviewing a risk management file takes hours to days — and again with every change.	A run takes minutes and reviews every line the same way — repeatable as often as you like.
You hope you haven’t missed anything the notified body or the authority will find later.	You review against a written yardstick, and every result is evidenced.
You could not judge what a purchased tool is worth.	You have validated a system against defined criteria — and know how to validate it in line with ISO 13485.
Review criteria live in people’s heads.	The review criteria live in a company-wide agreed model that can be extended to further chapters and products.
AI topics sit with IT. You wait for capacity that never frees up.	You drive them yourself in your department — and help decide how your company reviews.
“AI” is a topic passing you by.	You have a working system — and you are the person in the company who can do this.

Seven modules, one per week

From 1 December 2026, we unlock one module every Tuesday. When you work on it is up to you.

Zero phase (from 1 December): basic videos and self-tests — and this is where you set up your computer. So your setup is ready before you start module 1.

Module	Unlocked	Topic	What you have at the end of the module
1	Tue 1 Dec	From the Word checklist to formalised review criteria (part 1)	Your review checklist
2	Tue 8 Dec	Formalised review criteria (part 2)	Your data structure for review results
3	Tue 15 Dec	Review heuristics	Your blueprint with review rules
4	Tue 22 Dec	Reviewed file	Your first review result
5	Tue 29 Dec	Review report	Your HTML report
6	Tue 5 Jan	Automated process	Your run across a complete risk management file
7	Tue 12 Jan	Validated tool (validation in line with ISO 13485, benchmark)	Your system, validated on the example — the computer system validation is traceably documented
—	at your own pace	Completion	Your certificate of attendance and a plan for extending the system to further chapters

How modules are unlocked:

from 1 Deca new module every Tuesday from 31 Decall modules on the platform

Want everything at once? On request, we unlock all modules for you. Plan for around 2–3 hours a week; we recommend eight weeks, about 17–25 hours in total.

The author of the content

Prof. Dr. Christian Johner

20+ years advising medical device manufacturers
Author of the AI guideline used by notified bodies for their reviews
Member of standards committees
20,000+ seminar participants
Awarded Germany’s best professor

Since the beginning of the year, I have been building a comprehensive review system — prompts, data structures, processing pipeline — and have validated it on a large number of real technical documentation files. Every weekend, every holiday week; the data models in it are the result of years of work. Over the summer, this became exactly the system you build in the seven modules.

So what you get here is not course material invented for a course — and for you, that means: you are not building the first draft, but the version that has proven itself. More than four hundred versions of the review criteria and data structures have gone into it, and I discarded forty approaches along the way; those are the detours you don’t have to take. That is why your time goes into what only you can do anyway: tailoring this material to your products and your review criteria.

Why you can trust me

20+years

1,000+companies

20,000+seminar participants

No. 1Germany’s best professor

Your investment: Make or Buy

Build further review aspects yourself – or get all of them ready-made. All prices excl. VAT.

Make: On-Demand

You build the system – and extend it yourself

€3,490excl. VAT · introductory price until 30 Nov 2026, regular €3,990

1 person

Zero phase (basic videos + self-tests)
7 modules on video, unlocked weekly from 1 Dec
Assignments, model solutions, self-tests
Lessons-learned videos
Example file + base IP for intended purpose and risk management
Claude Standard: 4 months (1 Dec 2026 – 31 Mar 2027), extendable
Certificate of attendance
E-mail support (reply within 2 working days)
All 11 further review aspects, fully worked out
Add-ons available

Book Make →

Complete package

Buy: On-Demand + review aspects

You build the system – and get all further review aspects ready-made

€23,480excl. VAT · introductory price until 30 Nov 2026, then €29,990

1 person

Zero phase (basic videos + self-tests)
7 modules on video, unlocked weekly from 1 Dec
Assignments, model solutions, self-tests
Lessons-learned videos
Example file + base IP for intended purpose and risk management
Claude Standard: 4 months (1 Dec 2026 – 31 Mar 2027), extendable
Certificate of attendance
E-mail support (reply within 2 working days)
All 11 further review aspects, fully worked out
Add-ons available

Book Buy →

Shop prices for small and medium-sized enterprises. Larger companies and groups: request an offer.

What distinguishes Make and Buy: the course is identical. With Make, you build each further review aspect yourself using the method from the course. With Buy, you also get all 11 further review aspects fully worked out: usability, software, clinical evaluation, MDR/IVDR Annex I, MDR Annex II, design inputs, AI Act, cybersecurity, labelling & UDI, post-market and IEC 60601-1 — saving you that work.

On-Demand and live compared

	Zero to Hero Live (sold out)	Zero to Hero On-Demand
Contact with Christian Johner	yes	no
Lessons-learned videos	—	✓ short videos on the most common hurdles from the live programme
Completion	“Certified MedTech AI Practitioner” certificate	Certificate of attendance
Start	27 Oct 2026, fixed dates	1 Dec 2026, weekly unlocking, your own pace
Content, example file, model solutions, base IP	✓	✓ identical

Add-ons

Access to the Johner Academy

Online courses of the Johner Academy: LLM basics, structured data for AI (JSON/XML), regulatory basics for using AI. Can be combined with Make and Buy — also later.

€990 / 12 months

Then renewed annually; cancel up to 14 days before the end of the term.

Extend Claude access

Extends your Claude access beyond 31 March 2027 by 4 months.

€600 / 4 months

Charged per person. No automatic renewal: you book each further extension yourself if needed.

For larger companies and groups

Make and Buy in the shop apply to small and medium-sized enterprises as defined by the EU (fewer than 250 employees and a turnover of no more than €50 million or a balance sheet total of no more than €43 million; membership of a group counts). We check this before unlocking access.

For larger companies and groups, there is a company licence and dedicated packages — for example with fully worked-out review aspects or a TD review pipeline. Leave us your contact details — our sales team will get back to you with an individual offer.

The investment in context

An external TD review regularly costs a high five-figure sum — every single time.
An RIMS or digitalisation project runs into six or seven figures.
A delayed approval or an audit finding costs six figures and upwards — in revenue or in risk.
What you build here stays in-house and can be extended to further chapters and products.

Why the programme costs so much less

Because nobody here does the work for you. External reviews and digitalisation projects are expensive because consultant hours are billed — every time anew. In this programme, you build the system, once, and keep it. The groundwork is in the material you receive with the course — it has been done once, for everyone together. That is why the price can be where it is.

And there is a reason that matters more to me than the calculation: I want our medical device manufacturers to keep their chance in global markets — and their employees to keep their jobs. Both are under threat. Those who learn to master AI in regulatory affairs now keep both options open.

What your IT and management need

You rarely decide this alone. That is why everything the other stakeholders need is ready here — now, not after the purchase.

IT approval package

Which programs are installed, which network approvals are needed, which rights are required on the work computer; plus the data protection and contractual commitments with references, and a separate section on what is expressly not guaranteed.

For IT, information security, data protection

Download PDF English version

Decision template

Benefits, effort, costs and risks at a glance, so your management can assess the investment and choose between Make and Buy.

For management, executive board, budget owners

Download PDF

Terms and conditions

The special terms and conditions for Z2H On-Demand — scope of services, payment, cancellation, rights of use. The programme is aimed exclusively at businesses within the meaning of § 14 of the German Civil Code (BGB).

For procurement, legal

Download PDF As of October 2026 · the German version is legally binding

Data protection information

Which personal data we process to run the programme, on what legal basis, for how long — and what rights participants have.

For data protection, works council, participants

Download PDF As of October 2026 · the German version is legally binding

At a glance

What you book, in one list.

Your own review system — on your computer; what you build belongs to your company
7 modules on video (30–45 minutes each), unlocked weekly from 1 December 2026, available for 12 months
An assignment, model solution and self-test for every module
Lessons-learned videos on common problems
Zero phase with basic videos and self-tests
IP-protected Claude access included (4 months, until 31 Mar 2027) — plus approval package for your IT
Base IP: review criteria, data structures and scripts for intended purpose and risk management
Validation in line with ISO 13485 on the example in module 7 — traceably documented
Certificate of attendance and e-mail support
With Buy: all 11 further review aspects, fully worked out

Introductory price only until 30 November

We sell Z2H On-Demand from 19 October to 30 November 2026 at introductory prices: Make €3,490 instead of €3,990, Buy €23,480 as an introductory price, then €29,990. After that, the sales window closes; the next one opens in 2027 at the regular price. Everyone starts on Tuesday, 1 December 2026.

The sales window closes on 30 November.

Seven modules. One system. Yours.

Starts on 1 December 2026. Introductory price €3,490 until 30 November.

Choose Make or Buy →

All prices excl. VAT · invoice to your company

Frequently asked questions

How does On-Demand differ from the live programme?

On-Demand does not include direct contact with Christian Johner. Instead of the “Certified MedTech AI Practitioner” certificate, you receive a certificate of attendance. Content, example file, model solutions and base IP are the same as in the live programme. In addition, you get lessons-learned videos on the most common hurdles from the live programme.

Do I need programming skills?

No. If you work with Word and can copy text, that is enough. To be sure, our head of HR, Susanne Exler, went through the entire programme in advance — and she made it.

Will the system cover my entire technical documentation at the end?

In the course, you build your system for two review aspects: intended purpose and risk management. These two are the worked example on which you learn the method — from the review criterion via the data structure to the validated run.

For each further review aspect, you follow the same path again (Make). Or you choose the Buy package and get all 11 further review aspects fully worked out: usability, software, clinical evaluation, MDR/IVDR Annex I, MDR Annex II, design inputs, AI Act, cybersecurity, labelling & UDI, post-market and IEC 60601-1.

Are we building an AI agent?

No — and that is a deliberate decision. Your review system should work in a traceable and repeatable way: fixed review criteria, fixed data structures, a documented process. Exactly that can be validated. A freely acting agent cannot be validated. We use agentic tools where they belong: in building the system. The review itself then follows a fixed procedure that you are responsible for — and no AI takes that responsibility off your hands.

Doesn’t an AI deliver a different result with every run?

That is the central challenge. It is not brought under control by a better model but by craft: fixed review criteria, fixed data structures and a measurement that shows you how stable your system works. You build exactly this measurement in module 7. Reproducibility is not a by-product here, it is the topic.

When does it start, and how much time should I plan for?

Everyone starts on Tuesday, 1 December 2026: zero phase, Claude access and module 1. After that, we unlock one module every Tuesday, module 7 on 12 January 2027. From 31 December, all modules are on the platform; on request, we unlock everything at once. Plan for around 2–3 hours a week. The videos are available for 12 months.

Who answers my questions?

We answer questions about the process and the technology by e-mail within two working days. Personal support is not part of On-Demand. For most hurdles, there is the module’s model solution and the lessons-learned videos.

We don’t have any AI system except Copilot.

Access is included: Claude Standard from 1 December 2026 to 31 March 2027, IP-protected, without an IT project. Afterwards, you can extend it (€600 per 4 months). Copilot is made for writing, not for systematically reviewing entire files — that is why you build your own system here.

Does our data leave the company?

In the course, you do not process any of your company’s data — work is done exclusively on the example. For the AI working environment, the following applies: the provider (Anthropic Ireland, Limited) processes the inputs, also outside the EU. There is no training on your data, and the rights to the results belong to your company. We do not commit to processing exclusively within the EU.

The details are in the approval package for your IT — you can download it above and forward it directly. It backs up the commitments with references and also states what is explicitly not assured.

Do we work with our real files?

No. In the course, everyone works exclusively on the example technical documentation of a medical device — complete, with all files. Your company’s documents do not belong in the course environment; this is governed by the special terms and conditions. You transfer the method to your own files afterwards — with your company’s own AI contract.

Make or Buy — which suits me?

The course is the same in both packages. Make suits you if you want to learn the method and build further review aspects yourself. Buy suits you if you want the further review aspects in use quickly instead of working them out yourself. In both cases, you can evaluate them and adapt them to your review criteria — you learn that in the course.

Can we register several people?

Yes. Each place is for one named person; book one place per person in the shop. For larger companies and groups, there is a company licence via our sales team.

Who can buy in the shop?

Small and medium-sized enterprises as defined by the EU: fewer than 250 employees and a turnover of no more than €50 million or a balance sheet total of no more than €43 million. If your company belongs to a group, the group counts. We check this before unlocking access. Larger companies and groups receive an offer via our sales team.

Are there usage rules we need to confirm?

Yes. The special terms and conditions and the data protection information for participants apply — you can download both above. The key rules: work only on the example, do not enter personal data, do not pass on your personal access.

How and when can I book?

In the shop, from 19 October to 30 November 2026, at introductory prices: Make €3,490 (regular €3,990), Buy €23,480 (introductory price, then €29,990). You receive an invoice; if your company buys, it goes to the company. After 30 November, we will not sell On-Demand again until 2027.

The decision is yours

The review workload is rising, the time is not — this programme doesn’t change that. It changes who you are after seven modules: someone who has built, validated and deployed a review system in-house. Or someone who, a year from now, is still weighing whether to buy or build something like this.

You cannot buy this ability. You can build it — and it can be learned. What it costs is one decision now — and around 2–3 hours a week, at your own pace.

Afterwards, you have a working review system. That is the difference you see immediately — and it is significant. The second one shows later: you no longer ask whether something like this is feasible, but what you will build next.

Book now — introductory price until 30 Nov →

Sales window 19 Oct – 30 Nov · Starts 1 December 2026 · introductory prices until 30 Nov

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The review workload is rising. The time available is not.

Buy, build — or both?

What a TD review system finds

Two roles nobody can take off your hands

You write the yardstick

The responsibility stays with you

What you get

Your own TD review system.

Seven modules on video.

Lessons-learned videos.

A model solution for every module.

The zero phase.

AI access is included — and you work in it agentically.

The base IP — your starting point instead of a blank page.

Certificate of attendance and e-mail support.

Is On-Demand right for you?

This is for you if …

This is not for you if …

Your result after seven modules

Seven modules, one per week

Prof. Dr. Christian Johner

Why you can trust me

Your investment: Make or Buy

Make: On-Demand

Buy: On-Demand + review aspects

On-Demand and live compared

Add-ons

Access to the Johner Academy

Extend Claude access

For larger companies and groups

The investment in context

Why the programme costs so much less

What your IT and management need

IT approval package

Decision template

Terms and conditions

Data protection information

At a glance

Introductory price only until 30 November

Seven modules. One system. Yours.

Frequently asked questions

The decision is yours

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