Glossary Term
Requirements Management
Definition
Requirements management is the process of identifying, documenting, analyzing, tracking, and controlling the requirements for a product or project throughout its lifecycle. In the context of medical devices and healthcare, requirements management involves gathering and managing the technical, regulatory, and user requirements that ensure the product meets safety, efficacy, and performance standards. This process is essential for aligning stakeholders, guiding product development, and ensuring compliance with regulatory standards such as FDA regulations or ISO standards.
Relevance to the MedTech Industry
Requirements management ensures that all necessary product specifications, stakeholder needs, and regulatory requirements are clearly defined, understood, and met throughout the lifecycle of a medical device. Effective requirements management helps ensure that products are developed to meet clinical needs, comply with regulatory standards, and function as intended, ultimately ensuring patient safety and product success.
Additional Information & Related Terms
Related Terms
ISO 13485: An international standard for quality management systems in the medical device industry, outlining the requirements for meeting regulatory and customer requirements for medical devices.
Verification and Validation (V&V): The processes used to ensure that medical devices meet defined requirements and fulfill their intended purpose in clinical settings.
Change Control: A structured process for managing modifications to requirements, ensuring that all changes are documented, analyzed, and communicated to relevant stakeholders.
Traceability Matrix: A tool used in requirements management to ensure that all requirements are properly traced from their origin to final product validation, often used for regulatory submissions.
Risk Management: The process of identifying, assessing, and mitigating risks associated with medical devices, ensuring that product safety and performance requirements are met.