• Free MedTech Regulatory Consultation

    Short Expert Assessment for Medical Devices, IVD, and AI

    Available for a limited time: April to June 2026

Are you facing a regulatory decision or planning a new MedTech project?

Take advantage of our complimentary short consultation to experience our expertise firsthand - professionally and without obligation.

This offer allows you to gain insight into our consulting approach. It is ideal for organisations facing regulatory challenges, seeking clarity on specific questions, or planning a new MedTech project. Whether your question relates to international medical device approvals, AI in healthcare, cybersecurity requirements or, in vitro diagnostics (IVD), we provide an initial expert assessment tailored to your specific situation. You will  receive a response. If your inquiry cannot be fully addressed within the scope of this offer, we will  provide a qualified preliminary assessment along with recommendations for next steps and prioritisation. This gives you not only an initial answer, but also insight into how we think and work.

What to Expect

Our short consultation is designed for professionals and companies seeking to clarify a specific regulatory compliance question. At the same time, it offers an opportunity to learn about our approach – without obligation. You will receive an initial expert assessment that provides orientation and supports your next steps. Professional, practical, and free of charge.

Typical Topics:

   Worldwide medical device registrations (USA, EU, China, Brazil, Canada, Japan, etc.)
   AI and cybersecurity in MedTech – regulatory requirements for connected medical devices
   IVD regulatory requirements and global IVD registration

You Will Receive:

   An initial assessment of your specific regulatory inquiry
   Orientation on possible next steps
   Insight into our expertise and way of working

Your Benefits

Expert assessment with no commitment
Direct access to experienced regulatory specialists
Quick response without administrative hurdles
Opportunity to get to know how we work
Free of charge – an invitation to connect

Our Commitment

Every inquiry is reviewed individually and handled by experienced consultants.
We take the time to understand your question and provide assessments that genuinely help you move forward.

Submit your question

Your Contacts

Our experts have extensive experience in regulatory consulting for medical devices worldwide. They understand the requirements of all major markets and support companies in achieving regulatory compliance and successful market approval.

Nina Nowka

Head of Regulatory Affairs
 

Alicja Ritz, PhD

Senior Expert Regulatory Affairs Manager & Senior Expert IVD

Matthias Steck

Senior Expert Consultant Digital Health & Cybersecurity

Samuel Kilchenmann, PhD

Senior Expert Consultant Digital Health & AI
 

How It Works

1. Submit your question:

via the online form

2. Receive feedback:

We review your inquiry and respond within one week

3. Experience the consultation:

in writing or via Microsoft Teams

Free MedTech Regulatory Consultation

– The complimentary short consultation may be used once per company

– If your inquiry exceeds the scope of the short consultation, we will inform you promptly and propose suitable alternative options

– Your inquiry will be treated confidentially and is non-binding for you

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