Testing along the way

Concept and Feasibility Testing

Early-stage testing helps identify potential design flaws and feasibility issues, allowing for rapid iteration and refinement. It ensures that the concept is viable and aligns with the intended use.

Design and Development Testing

To assess the functionality, performance, and safety of the device as the design evolves.

This stage involves rigorous testing of prototypes to evaluate their mechanical properties, durability, and user interactions. Testing here is crucial for refining the design, ensuring it meets all specifications, and preparing it for more formal verification and validation.

Verification Testing

To confirm that the device meets all design specifications.
Verification testing is essential to ensure that the device performs as intended under various conditions.

It helps identify any discrepancies between the design and the actual performance, ensuring that all requirements are met before proceeding to validation.

Validation Testing

To demonstrate that the device meets the needs of the end-user and regulatory standards.

Validation testing is critical for proving that the device is safe and effective for its intended use. This stage typically involves testing under real-world conditions, and the results are often required for regulatory submissions.

Clinical Testing

To evaluate the device’s performance in a clinical setting.

Clinical testing provides real-world data on how the device functions in the hands of healthcare professionals and patients. It’s vital for assessing the device’s safety and efficacy in a clinical environment, forming the basis for regulatory approval and market entry.

Manufacturing and Quality control Testing

To ensure consistent production quality and performance.

Testing during manufacturing ensures that each device produced meets the established quality standards. It’s essential for maintaining product reliability, safety, and compliance with regulatory requirements.