Why Choose Reliant FDA Experts?

Design Control Programs

Design controls are an interrelated set of practices and procedures (i.e., a system of checks and balances) that are incorporated into the design and development process. Systematic assessment of the design becomes an integral part of development and as a result there is a greater likelihood that the design transferred to production will translate into a device that is appropriate for its intended use. Because design control regulations must apply to a wide variety of devices, the regulations provide a framework rather than specific practices so that there is sufficient flexibility for manufacturers to develop design controls that are both compliant and appropriate for their own design and development process. As such, it is critical that the intent of the regulation is understood and that the design control program that is developed complies with these intents.

SAMPLE TASKS TO INCLUDE IN A DESIGN AND DEVELOPMENT PLAN

  • Time involved for each major task
  • Resources and personnel required
  • Allocation of responsibilities for each major task
  • Prerequisite information necessary to start each major task
  • Interrelationship between tasks
  • Form of each task output or deliverable
  • Constraints (i.e., applicable codes, standards, and regulations)

EXAMPLES OF THE HELP RELIANT CAN PROVIDE

  • Build a Sustainable Design Control Program
  • Audit, Assess, and Provide Recommendations on an Existing Design Control Program

ASSOCIATED JOURNAL ARTICLES AND COMPLIANCE TIPS
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