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Get to know your trainer  
Anja Kuhnert spent many years working as a manager responsible for quality and regulatory affairs at various medical device manufacturers, where she gained firsthand experience with the…  
Digitalisation & AI  
We support medical device manufacturers, their suppliers, notified bodies and authorities in their holistic digital transformation and the integration of AI technologies into all areas of their…  
Revocation  
Would you like to exercise your right of withdrawal? Simply fill in the form with the required details, send it off – and we’ll take it from there: we’ll process your request as quickly as possible…  
Get to Know your Trainers   
Tina Priewasser holds a Ph.D. in bioinformatics and conducted postdoctoral research on the simulation of sequence evolution. Tina then gained over 8 years of experience at a biotech startup, which…  
Regulatory Strategy  
We help you develop the right regulatory strategy so that your medical devices can be approved quickly and safely in the desired market.  
Guided Clinical Evaluator  
Discover the Guided Clinical Evaluator – your solution for the autonomous creation of clinical evaluations.  
Who conducts the clinical evaluation?  
Who conducts the clinical evaluation? Your dossier will be prepared by experienced specialists who closely integrate regulatory and medical requirements.  
How does the collaboration work?  
How does the collaboration work? At the start of the project, we hold a joint kick-off meeting. Transparent planning, regular updates and close communication form the basis of the entire…  
Which documents are required?  
Which documents are required? To prepare the assessment, we require all relevant documents in advance, such as the product description, technical documentation, risk analysis and existing PMS/PMCF…  
Is my documentation safe with you?  
Is my documentation safe with you? Yes, we handle your data with utmost care and confidentiality. It is stored on certified infrastructure within the EU. You decide whether and when your documents…  
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