Zign Group

Zign Group: your partner for medical device development and contract manufacturing

What we believe.

We're passionate about bringing new products to life. From innovative ideas to scalable production and regulatory compliance (MDR/FDA). Our applications are typically safety critical and contribute to a healthy and sustainable world. 

How we work.

The development of medical devices requires accuracy and safety at every level. As a result development projects are generally known to be expensive depending on the device's complexity, classification and regulatory pathway. Our approach focuses on reducing risks early in the process while keeping initial investments low. That’s why we have divided our development process into 5 phases, each with clear milestones that gradually lead to the final product:

1. Concept Design: at the start of a product development project, ideas are still taking shape. Design inputs are gathered through for example market insights, user/patient needs, regulations and proof-of-concepts. All converging to a clear and feasible product description. 
2. System Design: in this phase we focus on defining the optimal technical solution. We combine a user-friendly industrial design with robust electronics and reliable software. It's a critical step that sets the foundation for all subsequent development work, including electronics, software and mechanical aspects. A well-executed System Design minimizes risks and ensures a smoother path toward a successful product.
3. Implementation: this phase marks the transition to the practical execution of the design. Our hardware/software/mechanical engineers 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. Naturally our development processes, design controls and documentation are compliant with the applicable standards:
   • IEC 60601: for safety and performance of electrical medical devices
   • IEC 62304: for governing the development and lifecycle of medical device software
   • IEC 62366: regarding human factors engineering for optimal usability
   • ISO 14971: risk management for medical devices
4. Industrialization: after initial verification and validation of the prototype we prepare the design for large-scale production. In the design transfer process we ensure that a reliable supply chain with all the necessary tooling and equipment is established and validated. The outcome of this phase is a qualified production line with an initial batch that is typically used for final validation and certification.
5. Manufacturing: after regulatory approval, the execution of the mass production according to your forecast is the culmination of our collaborative efforts. Our comprehensive approach allows you to focus on your core business while we expertly handle every aspect of the supply chain, from sourcing raw materials to delivering finished products. Discover how partnering with Zign can help you streamline your operations, reduce costs and achieve your goals.