Elevating healthcare with advanced medical devices.
Drug Device Combination Products
A combination product can be defined as a therapeutic or diagnostic product comprising drugs, medical devices, and biological products. A combination product usually has at least two components and sometimes all three.



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Design Controls for Medical Devices are an essential aspect of the development and manufacturing process to ensure the safety and effectiveness of these devices.Â
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Design Controls for Medical Devices are an essential aspect of the development and manufacturing process to ensure the safety and effectiveness of these devices.Â
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At 3i Concept, we specialize in providing expert consultancy for businesses seeking to file with the notified body in accordance with the EU Medical Device Regulation (MDR 2017/745).Â





Performance Testing involves evaluating the performance characteristics of a medical device, such as accuracy, precision, sensitivity, specificity, and response time.

Performance Testing involves evaluating the performance characteristics of a medical device, such as accuracy, precision, sensitivity, specificity, and response time.

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With a combined experience of many years in the industry, we have a deep understanding of the unique challenges and requirements of the medical device sector.
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