Design input
Product requirements are our top priority, and here’s why: - Ensuring quality and conformity: our main task is to deliver high-quality medical devices that meet all legal requirements. Quality is achieved when the end product functions as intended and fulfills its purpose. This starts with clearly defined design requirements that serve as the basis for the entire project. Every feature and function of the medical device can be traced back to these initial design specifications, which precisely guide each stage of development. - Early classification of the device: The classification of the medical device at the beginning of the project is crucial. By defining the classification early on, we can create a strategic roadmap for certification from the outset, ensuring a smooth process. - Defining the high-level architecture: The design input defined in the initial phase shapes the high-level architecture of the medical device. This architecture serves as an important guideline and provides a clear framework for all subsequent iterations and refinements.
- Basis for acceptance: The acceptance tests that confirm that the system fulfills the intended purpose for the customer depend entirely on the design input requirements. These tests focus solely on whether the system meets the specified requirements — and not on the design details or implementation methods (unless certain constraints apply). Without a thorough understanding of the design inputs, it is impossible to achieve customer acceptance. - Drive optimal solutions: Clearly defined design input requirements increase the likelihood of delivering an optimal solution. If the requirements are vague or incomplete, the resulting system may not fully meet expectations. Furthermore, validation based on these requirements alone is no longer possible and jeopardizes the success of the project. - Full traceability: Full traceability is non-negotiable. Each element of the system must be directly linked to the original design inputs. This traceability is essential for effective verification and validation. It forms the backbone of our quality assurance process and ensures that the medical device reliably fulfills its intended use.