Engineering for the Development of Medical Products

Bresslergroup provides full service engineering support throughout the design and development process for a wide range of medical products, devices and systems. Unlike consumer and industrial product development processes, the FDA requires stringent design documentation for the development of a medical product. We work closely with our clients to follow appropriate design and documentation guidelines to ease the FDA submission process. We use the following recommendations from the FDA for guidance

The manufacturer (including specification developer) must establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met [820.30(a)]. Design controls include establishing and maintaining plans that describe the design and development activities and also define responsibility for implementation [820.30(b)]. The plans must identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process [820.30(b)]. The design process also includes:

• Conducting a risk analysis [820.30(g)];

• Identifying design input or requirements for the device [820.30(c)];

• developing the design output or specifications for the device [820.30(d)];

• Identifying design input or requirements for the device [820.30(c)];

• verifying that the design output meets the design input [820.30(f)];

• holding design reviews at appropriate points during the design process to identify significant problems with the design or the design process [820.30(e)];

• validating that the design meets defined user needs and intended uses [820.30(g)];
• validating any software used in the device [820.30(g)];
• transferring the device design to production specifications [820.30(h)];
• controlling changes to the design during the design process and changes in the design of products on the market [820.30(i)];
• documenting design control activities in the design history file [820.30(j)].

The manufacturer must have procedures in place and must maintain documentation in the design history file to demonstrate compliance with the design control requirements of §820.30 and completion of the activities identified in the design plan. The design history file must be made available for FDA inspection. FDA will evaluate the adequacy of manufacturers' compliance with design control requirements during routine quality systems inspections for all classes of devices subject to design control.

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