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1352 Search result(s):
Computerized Systems Validation  
We help you set up a lean CSV process to validate relevant computer systems and document them in a regulatory-compliant manner.  
International Approval  
International approval of medical devices: Bring your medical or IVD medical device to all markets in the world in a predictable and safe manner in accordance with all regulatory requirements.  
US Market Access  
Bring your medical and IVD medical devices to market in the USA in just a few months through the 510(k) or De Novo Procedure.  
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.  
Performance Evaluation Strategy for IVD Medical Devices  
We help you develop a targeted performance evaluation strategy that is optimally suited to the intended purpose of your in-vitro diagnostic medical devices.  
In-house Production of IVD Medical Devices  
Achieve IVDR compliance for your health institution (e.g., your medical laboratory) and your in-house IVD medical devices in the shortest possible time.  
Regulatory Due Diligence  
Our comprehensive regulatory evaluation provides you, as an investor or buyer, with a clear basis for your investment decision.  
FDA Inspection & Remediation  
With our support, you will pass FDA inspections successfully and quickly eliminate deviations in remediation.  
Risk Management  
Pass approvals, audits, and reviews quickly and easily with legally compliant risk management files and safe medical devices.  
Software & (IVD) Medical Devices with AI  
We help you to efficiently develop and successfully approve your software medical devices and IVD software – including AI-based medical devices.  
Results 221 until 230 out of 1352
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