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US Agent  
We are your reliable partner for legally compliant communication with the FDA and, as your US Agent, ensure your market access in the USA.  
Quality Management Representative  
As your experienced external quality management representative, we ensure regulatory compliance of your quality management system.  
Person Responsible for Regulatory Compliance (PRRC)  
We take on the role of the Person Responsible for Regulatory Compliance (PRRC) according to MDR and IVDR and ensure your regulatory compliance.  
Authorized Represen­tative Services & Regulatory Roles  
Authorized Represen­tative Services & Regulatory Roles  
In-Country Representation  
We are your trusted authorised representative for medical devices in Europe and Switzerland, your designated representative in the United Kingdom, and your US agent in the United States, thereby…  
Case Studies  
We are the right partner to assist you with all regulatory matters and issues related to medical technology. See for yourself with our case studies.  
Post-Market Radar Demo Booking  
Stay informed and compliant with Post-Market Radar – for maximum security in your post-market surveillance.  
Regulatory Radar Demo Booking  
The Regulatory Radar keeps you updated with the latest global medical technology and pharmaceutical industry regulations. Book your free demo now.  
Regulatory Intelligence Demo Booking  
Our Regulatory Intelligence SaaS keeps you up to date through regulatory monitoring and ensures company-wide compliance. Book your free demo now.  
Clinical Evaluation  
Pass approvals, audits, and reviews quickly and safely with legally compliant clinical evaluations. Thanks to our clinical affairs services.  
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