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Design Controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g. Medical devices).

Medical devices

Since 1990, the Food and Drug Administration (FDA) has required that medical device manufacturers that want to market medical devices in the USA follow Design Control requirements (21 CFR 820.30). At a high level, this regulation requires:

  • Establishment of an intended use and design inputs
  • A design plan
  • Periodic design reviews throughout the design process
  • Confirmation that the design outputs conform to the design inputs through:
  • Design verification ("did we design the device right?")
  • Design validation ("did we design the right device?")
  • Translation of the design into manufacturable specifications
  • Clear documentation of the entire process in a design history file or DHF.

The Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device. REQUIREMENTS OF FDA Subpart C--Design Controls

Sec. 820.30 Design controls. (a)General. (1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.

(2) The following class I devices are subject to design controls:

(i) Devices automated with computer software; and

(ii) The devices listed in the following chart.

Section Device 868.6810 Catheter, Tracheobronchial Suction. 878.4460 Glove, Surgeon's. 880.6760 Restraint, Protective. 892.5650 System, Applicator, Radionuclide, Manual. 892.5740 Source, Radionuclide Teletherapy.

(b)Design and development planning. Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves.

(c)Design input. Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall 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). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.

(d)Design output. Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented.

(e)Design review. Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).

(f)Design verification. Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.

(g)Design validation. Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF.

(h)Design transfer. Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.

(i)Design changes. Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.

(j)Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.

ISO 13485 is a voluntary standard that contains section 7.3 Design and Development recommending which procedures should be put in place by manufacturers in order to have a quality system that will comply with MDD 93/42/EEC.

The objective of Design Controls, in this context, is to require that manufacturers follow a methodologically-sound process to develop a medical device, with the intent of improving the probability that the device will reach an acceptable level of efficacy and safety.

DESIGN CONTROL: Any Organization utilizes the design control process as a key part of the product realization process for all products. These activities may vary depending on the product Division, and if the products are manufactured in house, contract manufactured, or private labeled by another manufacturer. The Design Control process shall be controlled and documented per established procedures. An integral part of any Organization’s product development process is assuring that appropriate quality objectives and requirements are established, and that risk analysis is performed during the process to assure potential risks are addressed and minimized, either through design of the product or thru the product labeling process.

Design Inputs are established via customer feedback, customer input, market research or other methods and are an integral part of establishing the product requirements relating to function, safety, performance, and design. This includes a review and, where appropriate, filing of regulatory documentation. Risk assessment shall be performed to assure the product design or labeling adequately addresses and minimizes or eliminates potential risks.

Design Outputs: Are reviewed to assure all the requirements established during the design input phase have been met or addressed. This includes verifying the establishment of production, purchasing, and inspection systems, vendor or supplier qualification, approval of final product design (drawings, specifications, etc.) and other requirements as established in the Design Control Procedure(s).

Design Review is conducted at intervals during the product realization process to assure that the design meets requirements, identify and address any potential problems (including those in regulatory, material, manufacturing, supplier or other areas) and to if required, implement necessary changes under Organization’s Change Control Process.

Design Verification is performed to assure that the design and development process outputs meet the requirements established during the design input and development stages.

Design Validation is performed to ensure the end product is capable of meeting the requirements for its intended use. This can include clinical review, simulated use testing, customer evaluation or other methods. The final product will not be transferred to production until all required design verification and validation processes are complete.

Design Transfer: Once the final design is completed, the design will be transferred to production scale (this may be performed via the contract manufacturing process as well. The design transfer will be closely monitored to assure that the transfer goes smoothly and is properly transferred into production specifications.

Design Changes: Any changes to a new or existing design are handled such that design changes are documented, reviewed, validated and verified prior to full scale implementation.

Design History File: The documentation developed by the design process shall be compiled into a final Design History File for each type of device. The file contains and/or refers to the documentation that shows the product was developed in accordance with the approved design plan and inputs.

  • 21 CFR 820.30 on the FDA website [1]
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