Elevating Healthcare With Drug Device Combination Products!
What are 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.
Design Controls for Medical Devices are an essential aspect of the development and manufacturing process to ensure the safety and effectiveness of these devices.
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).
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.
About Us
Ensuring Quality and Compliance for Your Medical Devices
We are a medical device consulting company with deep industry experience. Our team works as a trusted medical device consultant for companies developing and manufacturing medical devices and drug device combination. We provide quality management and design history file support. We know what is expected on the regulatory front, technical issues and regulatory compliance requirements within the medical device industry.
The Significance of Drug Device Combinations Products in Therapeutic Innovation
Drug device combination products are a product that combines both drug and medical device functions into one overall system. These solutions include insulin pens, as well as, advanced wound care kits that add to the convenience and precision in patient care. As the need to use more and more integrated therapies, drug device combination products are an essential progressive move towards personalized medicine and regulatory innovation.
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Experience quality, Ensure compliance, Drive success with us!
Our team possesses years of individual experience and strives to work closely with clients in order to know their needs and fulfill them. We provide medical device development consulting with a clear emphasis on quality. We improve our offerings through practical, compliant, and efficient solutions that support long-term success.
- 12 Years of experience
- Regulatory compliance
- Improved processes
- Competitive advantage
- Continuous improvement
- Expert support
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