Medical Device Development

Technological advancements have revolutionized the medical sector, transforming simple instruments into advanced electronic devices that enhance diagnosis, treatment, and patient monitoring. Innovation, collaboration between medical professionals and engineers, and strict regulations are crucial for ensuring the safety and effectiveness of these products. Let's explore these key aspects further.

Why Zign as your partner for your Medical Device Development?

Every step of our process, from initial idea to final delivery, is driven by our documented Quality Management System (ISO 9001 & 13485 certified).

Our company specializes incompliance with key international standards for medical devices. These include IEC 60601, which ensures the safety and performance of electrical medical devices, IEC 62366, focusing on human factors engineering for optimal usability, IEC 62304, governing the development and lifecycle of medical device software, and ISO 14971, which outlines the risk management processes essential to maintaining safety and reliability in medical devices.
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Our solutions are not just innovative, they’re crucial for safety and make a meaningful impact on a healthier, more sustainable world.

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What is ISO 13485 certification and why is it important?

ISO 13485, specifically tailored to the medical device industry, forms the backbone of our quality management system. This certification enables us to effectively assess and control risks, from the development phase to the delivery of the end product. The result? Medical devices that meet the strictest safety standards and are reliable in their application. It is our responsibility to ensure that our products have a positive impact on the lives of patients, and with ISO 13485, we have the framework to achieve this.

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Clarification & Conceptual Design

In the first phase, Clarification & Conceptual Design, we set the tone for the project’s success. We take the time to fully understand and clarify the idea, in collaboration with our clients. The conceptual design that emerges serves as the foundation for the rest of the journey. We believe that a strong start is essential for a smooth and effective development process.

System Design

Next, we move on to System Design, where we define all the components and subsystems of the product in detail. Here, we establish the blueprint for functionality and interactions between different parts. Our team works closely to ensure that the design meets the highest standards of quality and safety, including the requirements of ISO 13485.

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Implementation

The third phase, Implementation, marks the transition to the practical execution of the design. Our technical experts get to work turning ideas into tangible prototypes. This is a phase of continuous improvement and optimization, where we iterate rapidly to further refine the product. Our three-week heartbeat allows us to stay flexible and respond quickly to changes and feedback.

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Industrialization

After prototyping comes Industrialization, where we prepare the design for large-scale production. We ensure that the manufacturing process is streamlined and efficient, without compromising on quality. This includes selecting reliable suppliers and establishing strict quality controls.

Mass Manufacturing

Last but not least, Mass Manufacturing is the culmination of our collaborative efforts. The product is now ready for large-scale production and distribution. Thanks to our partnership throughout the entire development process, we can guarantee that the end result meets all requirements and expectations. We remain engaged to ensure that the product is launched to the market with the same care and attention to detail as in the previous phases.

Medical Device Development

A guide committed to improving healthcare.

Why Zign as your partner for your Medical Device Development?

What is ISO 13485 certification and why is it important?