Glossary Term
Functional Requirements
Definition
unctional requirements define the specific behavior, capabilities, and functions that a system or product must exhibit in order to meet the needs of its users and stakeholders. In the context of MedTech, functional requirements specify how a medical device or software must operate, including what tasks it must perform, how it should respond to inputs, and the expected outcomes. These requirements are central to the design, development, and validation of medical devices, ensuring that the product fulfills its intended purpose in a safe and effective manner.
Relevance to the MedTech Industry
In MedTech, functional requirements ensure that medical devices, software, and systems meet regulatory standards and provide the necessary functionalities to address patient and healthcare provider needs. These requirements serve as the foundation for product design, testing, and post-market monitoring, aligning with both clinical and business objectives to guarantee the device performs as intended under real-world conditions.
Additional Information & Related Terms
Related Terms
Design Controls: Functional requirements are a part of design controls, which ensure that all aspects of product design meet specified criteria and are validated for safety and performance.
Verification and Validation: These processes ensure that the device’s functional requirements are met and that the device performs as expected in the real-world environment.
Risk Management: Functional requirements often include provisions for mitigating risks associated with device failure, ensuring patient safety and compliance with standards like ISO 14971.
ISO 13485: A quality management standard that guides the development of functional requirements for medical devices to ensure they meet regulatory and quality standards.
User Interface (UI) Design: Functional requirements play a critical role in defining how the device's user interface should function, ensuring ease of use and safety for healthcare providers or patients.