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.
Our Services
Empowering Your Business for Success
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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Support Design and Development Activities services provide businesses with expert assistance in the design and development of new products, systems, or processes.
QMS (Quality Management System) Development and Support Service provides businesses with a structured and systematic approach to managing their quality processes.
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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Support Design and Development Activities services provide businesses with expert assistance in the design and development of new products, systems, or processes.
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
Risk Management Process and Risk Management File services provide businesses with a systematic approach to identifying, evaluating, and mitigating risks.
Training and Educating your Staff service provides businesses with expert assistance in developing and delivering training programs for their employees.
General Support service provides businesses with a wide range of support services to help them manage their operations effectively and efficiently.
Risk Management Process and Risk Management File services provide businesses with a systematic approach to identifying, evaluating, and mitigating risks.
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 team of experts in the medical device industry, dedicated to providing quality management and design history file support to companies producing medical devices.
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.
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.
Testimonials
What Our Clients Say
QMS and DHF support helped us streamline our processes and achieve regulatory compliance. Their expertise and commitment to quality is unmatched.
Their personalized approach and attention to detail is what sets them apart in the industry. Highly recommend!
Our company has seen significant improvement since partnering with QMS and DHF support. They're the experts we trust.
Their team is knowledgeable, responsive, and always goes the extra mile. Highly recommended!
We couldn't have done it without the support of QMS and DHF. Their expertise and commitment to our success is unparalleled.
QMS and DHF support has been a valuable partner in ensuring the quality of our medical devices. Their expertise has been invaluable.
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Why Choose Us
Experience Quality, Ensure Compliance, Drive Success with Us.
Our team has extensive experience in the field and a commitment to meeting the needs of our customers. We prioritize quality in everything we do and are constantly seeking innovative ways to improve our offerings.
- 12 Years of experience
- Regulatory compliance
- Improved processes
- Competitive advantage
- Continuous improvement
- Expert support
Frequently Asked Questions
The company offers a range of innovative and effective pharmaceuticals and medical devices to meet the diverse needs of patients and healthcare providers.
The company has a rigorous research and development process, and all of its products undergo thorough testing and clinical trials to ensure their safety and efficacy. The company also closely monitors post-market data to identify any safety concerns.
The company is dedicated to finding new and innovative solutions to meet the needs of patients and healthcare providers. This includes a strong commitment to research and development, which is focused on discovering new treatments and technologies that can improve patient outcomes.
The company has a robust quality management system in place, which includes strict manufacturing processes, regular product testing, and ongoing monitoring of product performance.
In the event of a product recall or safety concern, the company has a well-established protocol in place to quickly address the issue, notify healthcare providers and patients, and take appropriate actions to correct the situation.
The company strives to make its products accessible and affordable to patients while also considering the significant investment in research and development and the ongoing costs of maintaining its product portfolio.
Testimonials
What Our Clients Say
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Grace Hill
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Jamie Carter
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Robert Owens
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