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1479 Search result(s):
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…  
E-Learning  
With our e-learning offerings, you can educate and train yourself individually and master the approval of your medical and IVD medical devices completely on your own.  
Podcast  
Our podcast keeps you well informed and allows you to talk to experts, auditors, and investigators on an equal footing.  
Johner Academy Book Demo  
Book your free & non-binding live demo for the Johner Academy now Our expert from the Johner Institute will guide you through the intuitive user interface and show you how you can gain confidence in…  
Seminar Risk Management and ISO 14971  
Learn how to coordinate the necessary risk management activities and create compliant documentation for your medical devices.  
Compact Seminar Requirements of the US FDA  
Learn about the basic requirements that the FDA imposes on the marketing of medical devices, which you and your company must know, understand, and fulfill.  
Results 271 until 280 out of 1479
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