iDE8 is a business-to-business medical device contracting agency that provides services and support for businesses in the life science and medical device industries. We aim to support and help our clients bring innovative, high-quality medical devices to market.
iDE8 understands that the medical device development process can be complex and challenging, so we offer a comprehensive range of services to support clients throughout the product development lifecycle. Our team of contractors has extensive experience in design, development, product validation, quality management, quality assurance, and process excellence expertise, all aimed at helping medical device businesses and their products meet their full potential.
Full support in developing and launching medical devices
iDE8’s experience in developing, launching, and sustaining Class I-III medical devices for businesses worldwide means we understand what it takes to bring a medical device to market. Our comprehensive range of services includes the design, development, and testing of medical devices, as well as quality control and assurance services.
Our team has more than 150 years of combined expertise in the medical device industry. They aim to provide exceptional service and support to clients and believe that success is built on strong working relationships. iDE8’s quality control lab services are focused on ensuring that each medical device meets and sustains the highest standards of quality and safety after it has been launched.
In addition to business quality control testing regimes, iDE8 offers lab-controlled complaint investigations for businesses to determine the root causes of any issues and develop corrective actions for them. We work closely with clients to ensure that all complaints are thoroughly investigated and addressed in a timely and effective manner.
Medical device design verification and validation services
iDE8’s team specialises in design verification and validation services, which are critical aspects of the medical device development process. These services help ensure that a medical device is safe and effective for patients and meets all regulatory requirements.
Design verification is the process of evaluating a medical device to guarantee it meets all the design input requirements. This includes functional, performance, and environmental testing against specific criteria to check the device meets the intended use and design objectives. Design validation ensures that the final design meets the user’s needs and is entirely safe for use, which involves checking the device against the intended use and user requirements.
Design verification and validation services are essential for ensuring that a medical device meets all regulatory requirements and is safe and effective for patients. iDE8’s services in this field can help identify potential design issues early in the product development process, reducing the risk of costly delays and reworking later on. Our team has extensive experience in designing and testing medical devices using the latest technologies and methodologies.
Medical device quality control and assurance services
In addition to design verification and validation, iDE8 can provide comprehensive quality control and assurance services for the entire product development lifecycle, from design and development to manufacturing and distribution. This includes testing prototypes, evaluating new product designs, and testing products during the manufacturing process.
Our team has extensive experience in quality assurance and can provide our clients with the guidance and support they need to ensure their products meet all regulatory requirements are safe for patients and work effectively.
The quality assurance services we offer include the development of quality management systems, design control and documentation, risk management, supplier management, and auditing services. We work closely with our clients to understand their specific needs and requirements and develop tailored quality assurance plans that meet their unique continuous improvement needs.
Guidance on improving the medical device development process
iDE8’s process excellence expertise enables us to work closely with clients to improve their manufacturing processes. This involves analysing each step of the product development process and internal quality systems to identify areas that can be improved while developing tailored solutions that meet clients’ unique needs.
Our team provides training and support to help businesses implement best practices and streamline their product development processes. This includes training in process improvement methodologies, as well as facilitating workshops on the use of tools and technologies that can help streamline operations.
iDE8’s experience in process excellence provides businesses with the guidance and support they need to optimise their product development processes, reduce costs, improve efficiency, and expedite time-to-market.
