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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…  
Can I also book individual services or modules?  
Can I also book individual services or modules? Yes, you can, for example, commission only the preparation of the clinical assessment, a literature review or an update.   
Are there any special offers for multiple products?  
Are there any special offers for multiple products? For manufacturers with a larger portfolio, we offer structured solutions – with transparent processes, bundled support and dedicated contact…  
How does the initial consultation work?  
How does the initial consultation work? In a short, no-obligation web conference, we’ll clarify your product details, the status of your documentation, your timeline and the model best suited to your…  
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