Design and development planning is needed to ensure that the design process is appropriately controlled and that device quality objectives are met As is usual, the FDA does not prescribe a specific approach.

FDA Statements

• 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.

References

• FDA Design Control Guidance for Medical Device Manufacturers, Section B:
  • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm#_Toc382720784
  • PDF available on that page: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf
• Section 820.30(b) of FDA Quality System Regulation
• ISO 9001:1994
• ISE/DIS 13485 Section 4.4.3 Organization and technical interfaces

Mapping

The following process elements satisfy this objective:

• Systems Engineering Workflow
• Med Dev - SW - ISDP 

More information:

• Release Planning
• Iterative Development
• Setting up a Performance Measurement System
• Managing Performance through Measurements
• Method Development
• Project Process Tailoring