Wondering how to bring your AI-powered medical software through certification — safely and fast?
We clear you a straight path through the mountain of MDR documentation, letting AI sweep every bureaucratic hurdle aside — without ever compromising on safety.
I guide you through the entire documentation. Every piece of information you give me, I file straight into all the relevant documents — so we save a lot of time. Your part is to fill in the gaps, learn where it helps, and review my results. Whenever you like, our AI and regulatory experts are on hand for advice. Shall we get started? Sign up today — we can’t wait to meet you and your product!
Your personal compliance guide
Tobi Task, your project manager. Tobi walks you through every task in conversation. Tobi Task, the project-management tool, gives you a full overview of product development and regulatory tasks at any time. References are linked directly across every task and document — you can see them on the right. So you always know the regulatory basis for your decisions, and come the audit you won’t just pass — you’ll shine.
Tobi is your navigator, always finding the best route for you. No two companies — and barely any two products — are alike, so standards and regulations only set the guardrails. We carry your gear and look for the shortcuts, and the time you save goes into your product instead of expensive regulatory paperwork. Once you grasp the structure, the mountain of bureaucracy turns into a clear path with defined roles and tasks — one your team can work through, calmly.
Your QMS makes sure everyone knows their role and their tasks — and that your processes reliably deliver the right results.
Everything connected. Tobi maps your organisation to roles, processes and the documents each one owns — rename, adjust, and the structure follows.
Your product development moves through phases the way a climber moves from camp to camp. Each phase ends in a review. Two safety ropes stay clipped to your product all the way to the top: risk management and usability. They run alongside development the whole time — and any climber will tell you they’re what makes the ascent safe.
Secured by your QMS and the documents approved there, you set off on the climb. Ready to plan your risk management? Tobi hands you the approved template from the QMS and guides you through it with the right questions. Tobi does the legwork, you do the review — with a final sign-off from our humans in the loop: Ella and Astrid.
Risk management & usability — running the whole climbBuyer, operator and user are not the same person. Define stakeholders cleanly, translate their needs into traceable requirements, and open risk management before the first line of code is written.
Now you build. The software architecture is documented, code references the exact requirements it implements, and the tests you planned run continuously alongside.
Tested under real conditions of use: can the real user operate it without error, can it be installed and manufactured as planned? Summative usability and the clinical evaluation report come together here.
Now the product moves out into the real world: Is the conformity assessment complete? Is the device registered? Has the notified body signed off? Are sales and service ready to sell?
Know your role in every phase. Tobi guides you through every phase of development in your role. And when you switch hats along the way — because you’re the PRRC and the risk manager at once, say — no problem: Tobi keeps pace. In the background, audit-proof, role-based documentation takes shape — a precise record of which role you handled which tasks in, and which sign-offs you gave.
Tobi knows where it pays to linger a little longer — when we set your regulatory and clinical strategy, for instance. Because after that, you can move at full speed. And the competition won’t wait: your product has to reach the market before it disappears in a storm of look-alikes.
So we’ve set ourselves an ambitious goal: seven weeks of pure documentation time to storm the summit together. Tobi carries the gear and shows the way, so you can focus on your product. We make sure you reach the top — and your innovation reaches the patient: safely, and before the weather turns.
The seven weeks cover pure documentation time for the QMS, the development file and the technical documentation. Clinical evaluation is included; a clinical investigation is not.
At the top, you watch it all come together: the QMS from base camp and the complete development documentation from camp to camp — now delivering the approved documents for your technical file.
Everything you finalised and signed off across the phases sorts straight into the structure the MDR requires — Annexes II and III — cross-referenced to the General Safety and Performance Requirements of Annex I.
While you climbed, step by step, Tobi filed it all into place — and the notified body can review without hunting for a thing.
Tobi links all content across every document. On top of that, every piece of content is tied to its regulatory requirements. When products, processes or people change, Tobi shows you at once which documents and content need updating to stay compliant. Review and sign-off workflows are triggered and guided by role.
That’s why the file stays current after the audit, not frozen the day you submit it — and why every future module update reaches your documentation automatically.
All in one place. One read-only dashboard ties the design history file, the technical documentation and the QMS together — always current, never re-keyed.
Everything above, produced in our platform and stood behind by people who have done this for decades.
Risk management, clinical evaluation, the technical file, QMS, software development and usability — the whole set, not a slice of it.
Authored in our platform with AI assistance, then reviewed by regulatory experts with Johner Institut background and 30+ years of MedTech experience.
Structured and prepared for your notified body from the first phase — so submission is a handover, not a scramble.
Your documentation stays connected and current, with every future module update included. Continue afterwards at fair pilot conditions.
Tobi carries the gear. The sign-off is human: every document you approve is reviewed by us before it goes near a notified body.
At taube_med, we believe regulatory compliance shouldn’t kill innovation.
For over 30 years, I’ve helped companies bring medical devices to market — and I’ve seen how exhausting and frustrating regulatory compliance can be, especially for startups.
The complexity, the endless PDFs, the fear of getting it wrong — it can easily overshadow great ideas and slow down innovation before it even starts.
That’s exactly why I started taube_med: an AI-powered platform that takes the heavy lifting out of documentation, explains every step, and gives startups the confidence to move forward — fully compliant, fully audit-ready.
Astrid Schulze · Founder & CEO
Astrid is a regulatory expert with 30+ years of experience in MedTech certification. At taube_med, she simplifies compliance for startups and SMEs.
LinkedIn
Ella is a computer scientist and entrepreneur focused on AI in medical imaging. At taube_med, she shapes the product strategy to empower innovation.
LinkedInQMS setups, technical documentation, DiGA, and inspections by the competent authority — here’s what it was like to work with Astrid.
We worked with Astrid Schulze on setting up our QMS and placing our first medical device on the market. Her strategic expertise and structured approach to complex regulatory issues in the field of medical software were of great value to us. Astrid has always succeeded very well in showing the big picture and thus communicating even complicated topics in an understandable way. I am pleased to be able to recommend Astrid to others.
Astrid is a competent partner for all things quality management and regulatory affairs. I have come to appreciate working with her in the field of medical software and digital health applications (DiGA). Her calm and focussed manner plays a key role in ensuring that even critical projects — inspections by the competent authority, for instance — are completed on time and without any complaints. Her holistic perspective ensures that people are not lost sight of, even under pressure. Whether technical documentation, clinical evaluation or QM system: Astrid is the right person for the job.
Astrid Schulze was very helpful in developing a regulatory strategy for our medical devices. By registering our products in a medical system, we were able to save a lot of time and money. Thanks to her project management, we completed the approval process within our time and budget.
Working with Astrid Schulze has always been a real support. She makes complex regulations clear and always adapts them to the realities of small companies. It’s rare to find someone who combines deep expertise with such practical thinking.
We’re looking for four makers of AI-powered medical software to build their complete MDR documentation with us — and shape the platform as they go.
Doubly regulated. Doubly prepared.
From August 2027, AI-driven medical software that needs a notified body — Class IIa and up — answers to both the MDR and the EU AI Act. The two interlock but aren’t identical — we address them together, with no duplication.
DiGA approval runs in two steps — MDR/CE first, then a DiGAV application with the BfArM. We set your regulatory and clinical strategy up to translate cleanly into that application.
The pilot study itself isn’t ours — we refer you to experienced partners.
Because we specialise in AI-powered medical software. The regulatory templates are prepared, the platform automates the heavy lifting — and as a pilot customer, you help us sharpen the product.
Comparable consulting projects typically run €40,000–€80,000.
Send us a message and we’ll reply personally at the email address you provide.
Or email us directly: info@taube-med.de
