Specifications and requirements are closely related but serve different purposes in the design and development process.

Requirements are statements that specify what the system or device should do, the functionalities it needs to have, or the constraints it must meet. They represent the needs, constraints, or goals that the device should satisfy. Requirements are often derived from and include user needs, use cases, regulatory standards, market demands, and other sources. They articulate the expectations and necessities of the end users, stakeholders, and regulatory bodies.

Specifications are detailed descriptions or technical criteria that outline how the system or device will meet those requirements. They provide specific, measurable, and often quantitative details about the design, components, performance, or other characteristics of the device. Specifications elaborate on the implementation details, materials, dimensions, performance metrics, interfaces, and other technical aspects required to fulfill the requirements.

Although Ketryx can't provide specific recommendations for how to directly draft and link specifications and requirements, several key considerations should be taken into account when drafting them.

1. Clarity and Precision: Ensure that both specifications and requirements are clear, unambiguous, and easy to understand for all stakeholders involved in the development process.

2. Traceability and Consistency: Maintain a clear traceability matrix using the traceability widget in Jira that connects each requirement to its corresponding specification and vice versa. This ensures consistency and helps in tracking how each specification aligns with the intended requirement. The traceability widget allows your linking to be as simple or as complex as you'd like. 

3. Measurability and Testability: Make requirements and specifications measurable and testable. Use quantifiable metrics or criteria to define both requirements and specifications whenever possible. This aids in validation and verification during the development and testing phases.

4. Relevance and Completeness: Ensure that the specifications directly address and fulfill the requirements. Specifications should cover all necessary technical details to meet the identified needs without being overly complex or ambiguous.

5. Compliance and Standards: Align specifications and requirements with relevant regulatory standards, and industry best practices. Ensure that the system or device complies with all necessary safety, quality, and performance standards.

6. Iteration and Revision: Recognize that specifications and requirements might evolve throughout the development lifecycle. Allow room for iteration, revision, and updates based on feedback, new insights, or changing user needs while maintaining proper documentation and version control.

7. Collaboration and Communication: Foster collaboration and effective communication among cross-functional teams, including engineers, designers, regulatory experts, and end users. Ensure that everyone involved understands and agrees upon the specifications derived from the requirements.

See the attached V-model for how Ketryx views the relationships between configuration items.