Through our many years of experience we developed an approach to design which helps our clients to clearly define their market needs. We deliver products meeting these requirements and provide support through human factors testing, regulatory approvals and manufacturing.
Disruptive Innovation is a term used by Duoject’s design team to define our approach to product development. We work with our client to clearly define their market needs with a focus on meaningful user experiences and human factors. With state-of-the-art rapid prototyping and performance testing facilities, our team of industrial designers and mechanical engineers will develop, test and validate solutions to deliver unique products that will meet your market needs.
Duoject’s Quality Assurance & Regulatory Affairs team coordinates the activities required to ensure that Duoject products are fit for purpose and meet both external and internal requirements, including regulatory and legal compliance and customer expectations. The team employs a variety of measures to place quality and regulatory at the heart of the organization, including management systems such as ISO 13485, philosophies such as Total Quality Management, Risk Management for medical device ISO 14971, and methodologies such as Continuous Improvement and Statistical Quality Control.
Following a design development project, the Manufacturing team will ensure a smooth transfer of technical and quality product specifications to highly qualified manufacturing sites. During this transition, manufacturing personnel will make it a priority to follow-up periodically with client on cost, quality and timeline requirements. All along throughout the transfer to production phase, the manufacturing team works hand-in-hand with the regulatory affairs team to support device procurement, testing and documentation