![[Translate to English:] AI act conformity](/fileadmin/user_upload/Header_1200x230_AI_Act_conformity.png)
– but it also brings with it complex regulatory challenges that can trip up even experienced development teams.
Between AI legislation, MDR/IVDR and constantly changing standards, an opaque set of rules is emerging that is difficult to navigate without expert knowledge. It's not just about the obvious hurdles: the real risks are often hidden in the overlaps between different regulations, where redundancies can lead to contradictions and dangerous gaps can cause costly delays.
We know these pitfalls from years of experience and understand that the difference between a failed and a successful AI integration lies in the right regulatory strategy from the outset.
The good news: with our proven 4-phase approach, we guide you through the entire compliance process in a structured and efficient manner – without detours or regulatory stumbling blocks.
![[Translate to English:] taking notes for quick check](/fileadmin/user_upload/Side_Photo_520x290_taking_notes.png)
![[Translate to English:] team training](/fileadmin/user_upload/Side_Photo_520x290_team_training.png)
What does this mean specifically for your company's success? Your advantages at a glance:
Maximum efficient QM system with full conformity
No delays from authorities or Notified Bodies
Avoid fines and market withdrawals
Optimized processes without redundancies
Clear responsibilities and workflows
Enablement for independent development
Let's make your AI products and tools compliant and successful together
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+49 7531 94500 20
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With us at your side, you can master regulatory challenges more efficiently, shorten your time to market and secure decisive competitive advantages in medical technology.
You are working with the number one in regulatory affairs – we bring market-leading expertise to all your medical technology regulatory issues.
Not only have we been pioneers in artificial intelligence since 2019, we are also the authors of the EU-wide AI guidelines for notified bodies.
We know your challenges from our own experience and use this knowledge to develop tailor-made solutions that work in practice.
You are working with the number one in regulatory affairs – we bring market-leading expertise to all your medical technology regulatory issues.
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