Design Input Sample Clauses
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Design Input. Design-input requirements relating to the product, including applicable statutory and regulatory requirements, shall be identified, documented, and their selection reviewed by Developer for adequacy. Incomplete, ambiguous, or conflicting requirements shall be resolved with those responsible for imposing these requirements. The essence of this sub-element is that Developer determines what information is needed and the available sources for information, reviews all pertinent available data, ensures that there is sufficient information to carry out its assignment, and resolves with IFA and other appropriate authorities any actual or apparent conflicts or inconsistencies in the information so gathered. The information, sources, and decisions taken shall be documented and treated as a quality record.
Design Input. The Marketing Requirement Specification and specific customer contracts are the source documents for the design input requirements. Technical engineering specifications are developed for the product and for defined subdivisions of the product. Detail requirements are refined during the design process.
Design Input. Establish the requirements for the Product to be developed. This should include appropriate hazard analysis outputs.
Design Input. M▇▇▇▇ shall ensure that the design requirements for the Product(s) are appropriate and address the intended use of the Product(s) including the needs of the user and patient, in compliance with the Quality Management System Requirements. M▇▇▇▇ has the sole authority to make design changes.
Design Input. Oversee and cause the Architect, when necessary, to provide design input and coordination so as to maximize efficiency and minimize costs.
Design Input. The Supplier shall have written procedures to ensure that the design requirements for the product are complete, understood and include, where applicable: 1. functional, performance, and safety requirements, 2. applicable statutory and regulatory requirements, 3. other requirements essential for design and development 4. application of risk management (see ISO 14971 for guidance) 5. provisions which address the intended use of the device, including the needs of the user and patient. The Supplier’s procedure is to include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s) of Siemens (except where Siemens is distributing a product for which the Supplier is solely responsible for the design requirements) and the Supplier. The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.