Requirements (Design Input)

The design control regulation requires that "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)."

Design Input and the documented requirements that comprise it has, arguably, been the most difficult and confusing aspect of design controls to implement for many companies. At first glance, requirements appear to many engineers to be simply a duplicate set of design specifications and thus are seemingly wasteful and unnecessary. It is necessary to understand the conceptual basis for writing requirements early in the development process before one can appreciate the power of requirements engineering to actually speed up the overall development cycle time and get the right products to market faster than otherwise possible.

Writing good requirements is a discipline all to itself as practiced in the relatively new field of requirements engineering. Developing a solid set of requirements before the detailed engineering work is undertaken is an approach that companies cannot afford to bypass in today's medical device marketing, engineering, quality, and regulatory environment.

Let us show you how to effectively use requirements engineering to help you get products that better meet your customer's needs to market more quickly.

We invite you to review some case studies that are representative of the work done by our consultants...

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