Design Controls definition

Design Controls means procedures established and maintained to control the design of a medical device in order to ensure that specified design requirements are met, which elements of design control may include: design and development planning, design input, design output, design review, design verification, design validation, design transfer, design changes, and design history files.

Design Controls means the Design Controls and any amendments made to the same including, without limitation, the Design Specifications and the Grading Requirements, and the expressions “herein”, “hereof”, “above”, “below”, and similar expressions used in any paragraph, subparagraph, section or article of these Design Controls shall refer and relate to the whole of these Design Controls and not to that paragraph, subparagraph, section or article only, unless expressly provided otherwise;

Design Controls means the Pier 70 Design for Development approved by the Port Commission and the Planning Commission, as amended from time to time.

Examples of Design Controls in a sentence

• The Level 2 QSIT approach was validated using the following inspectional sequence: Management Controls, Design Controls, CAPA and P&PC.

• Level 1 inspections should cover the CAPA subsystem, then P&PC or Design Controls, using the QSIT Guide.

• Information from Design Controls and CAPA may be used to select the products and processes for inspecting production and process controls, and appropriate linkages.

• Residential and major collectors in mountainous terrain must still meet the criteria in Table 4.7.Table 4.7 Design Controls for Geometric Design The standard design vehicles for the various classes of streets are also presented in Table4.7. Although the standard design vehicles are listed in the table, the design vehicle should be selected based upon the street classification and the existing and anticipated vehicle type and volume.

• This level of inspection (CAPA plus P&PC or Design Controls) may be used for routine surveillance and initial inspections of all firms, other than firms that manufacture Class III devices.

• Level 2 inspections will cover all four major subsystems (Management Controls, Design Controls, CAPA, and P&PC) as explained in the QSIT Guide.

• The selection of CAPA plus either the P&PC or Design Controls subsystem will provide an adequate review of the compliance status of the firm.

• The minimum transition section lengths shall be determined in accordance with the AASHTO Policy on Geometric Design of Highways and Streets 2004 Edition, Chapter 3 Transition Design Controls.

• The selection of the P&PC or Design Controls subsystem should be alternated over time so that more subsystems within a firm’s overall quality management system are assessed• Significant changes since the previous EI.

• The EIR must clearly state which subsystem, P&PC or Design Controls, was chosen and why.

More Definitions of Design Controls

Design Controls means the design and building requirements applicable to the

Design Controls means these Design Controls including any amendments made to the same, and the expressions “herein”, “hereof”, “above”, “below”, and similar expressions used in any paragraph, sub-paragraph, section or article of these Design Controls shall refer and relate to the whole of these Design Controls and not to that paragraph, sub-paragraph, section, or article only unless otherwise expressly provided;