Services

Empowering Your Business for Success

Design Controls For Medical 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.

Technical Services For Design And Development Of Medical Devices

Support Design and Development Activities services provide businesses with expert assistance in the design and development of new products, systems, or processes.

QMS Development and Support

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

Design Controls for Medical Devices are an essential aspect of the development and manufacturing process to ensure the safety and effectiveness of these devices.

Technical Services For Design And Development Of Medical Devices

Support Design and Development Activities services provide businesses with expert assistance in the design and development of new products, systems, or processes.

EU Medical Device Regulation

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).

Risk Management Service

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

Training and Educating your Staff service provides businesses with expert assistance in developing and delivering training programs for their employees.

General Support

General Support service provides businesses with a wide range of support services to help them manage their operations effectively and efficiently.

Risk Management Service

Risk Management Process and Risk Management File services provide businesses with a systematic approach to identifying, evaluating, and mitigating risks.

Testing Of Medical Devices And Drug Device Testing Support

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

Testing Of Medical Devices And Drug Device Testing Support

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

Empowering Your Business for Success

Support Design and Development Activities

Support Design and Development Activities services provide businesses with expert assistance in the design and development of new products, systems, or processes.

QMS Development and Support

QMS (Quality Management System) Development and Support Service provides businesses with a structured and systematic approach to managing their quality processes.

Risk Management Process and Risk Management File

Risk Management Process and Risk Management File services provide businesses with a systematic approach to identifying, evaluating, and mitigating risks.

Audit Readiness Planning

Audit Readiness Planning service provides businesses with expert assistance in preparing for internal and external audits. This service helps businesses to ensure that their systems, processes,

Training and Educating your Staff

Training and Educating your Staff service provides businesses with expert assistance in developing and delivering training programs for their employees.

General Support

General Support service provides businesses with a wide range of support services to help them manage their operations effectively and efficiently.

"Ensuring Quality and Compliance for Life-Saving Medical Devices"

Quality Management System (QMS) and Design History File (DHF) support for a medical device company involves ensuring compliance with regulatory requirements and industry standards for the design, development, and manufacturing of medical devices.