Medical Device Design Control: Design Review

As stated in § 820.3(h), "Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems."

Requirements:

• 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).

In general, formal design reviews are intended to:

• provide a systematic assessment of design results, including the device design and the associated designs for production and support processes;
• provide feedback to designers on existing or emerging problems;
• assess project progress; and/or
• provide confirmation that the project is ready to move on to the next stage of development.

The term "review" is commonly used by manufacturers to describe a variety of design assessment activities. Most, but not all, of these activities meet the definition of formal design reviews. The following exceptions may help to clarify the distinguishing characteristics of design reviews.

• Each design document which constitutes the formal output, or deliverable, of a design task is normally subject to evaluation activities, sometimes referred to as informal peer review, supervisory review, or technical assessment. These activities, while they may be called reviews, are often better described as verification activities, because they are not intended to be comprehensive, definitive, and multidisciplinary in their scope. Rather, their purpose is to confirm that design output meets design input. Verification activities affect and add to the design output, and are themselves subject to subsequent design review.
• Developers may conduct routine or ad hoc meetings to discuss an issue, coordinate activities, or assess development progress. Decisions from such meetings may not require formal documentation; however, if a significant issue is resolved, this should be documented. If the outcome results in change to an approved design document, then applicable change control procedures should be followed, as discussed in Section I (Design Changes).

Design Review Procedures

The manufacturer should have documented formal design review procedures addressing the following:

• Evaluation of the design (including identification of concerns, i.e., issues and potential problems with the design)
• Resolution of concerns
• Implementation of corrective actions

Type of Reviews

The number of reviews depends upon the complexity of the device.

• For a simple design, or a minor upgrade to an existing product, it might be appropriate to conduct a single review at the conclusion of the design process.
• For a product involving multiple subsystems, an early design task is to allocate the design input requirements among the various subsystems. For example, in a microprocessor-based system, designers must decide which functions will be performed by hardware and which by software.
• For complex systems, additional reviews are often built into the development plan. For example, engineering sketches may be developed for prototyping purposes prior to development of production drawings. Evaluation of the prototype would typically culminate in a formal design review. Similarly, software development commonly includes a high-level design phase, during which requirements are elaborated to a greater level of detail and algorithms are developed to implement key functions. A formal design review would typically be conducted to review this work prior to beginning detailed coding.

Source:

www.fda.gov

Related Training:

Design Controls Basics - From Design Inputs to Design Outputs