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1478 Search result(s):
Get to know your trainer  
As an engineer for biomedical technology, Christian Rosenzweig was responsible for basic and software development for complex active medical devices for many years. As the person responsible for…  
Auditgarant Book Demo  
The Auditgarant is the fastest and most cost-effective way to successfully market your medical or IVD medical device.  
Quality Management System  
Work productively again with a lean QM system without bureaucratic frustration and meet the requirements of ISO 13485.  
Market Access & Regulatory Affairs  
We help you gain access in all markets worldwide with your medical and IVD medical devices and make the right strategic decisions in regulatory affairs.  
Clinical Investigations & Studies  
We help you to achieve your market approval with lean clinical investigations.  
Legal Manufacturer  
We are your legal manufacturer and take full regulatory responsibility for your medical devices in Europe.  
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.  
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.  
In-country Representation  
We are your reliable authorized representative for medical devices in Europe and Switzerland, as well as your Responsible Person in the United Kingdom, and your US Agent in the USA, ensuring your…  
Results 261 until 270 out of 1478
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