![iso 13485 and 21 cfr 820 iso 13485 and 21 cfr 820](https://images-na.ssl-images-amazon.com/images/I/41DP80XHVVL._SX383_BO1,204,203,200_.jpg)
The plans shall be reviewed, updated, and approved as design and development evolves. 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. Requirements shall be complete, unambiguous, able to be verified or validated, and not in conflict with each other.Įach manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. These inputs shall be reviewed for adequacy and approved. These inputs shall include:Ī) functional, performance, usability and safety requirements, according to the intended use ī) applicable regulatory requirements and standards Ĭ) applicable output(s) of risk management ĭ) as appropriate, information derived from previous similar designs Į) Other requirements essential for design and development of the product and processes Inputs relating to product requirements shall be determined and records maintained. The approval, including the date and signature of the individual(s) approving the requirements, shall be documented. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements.
![iso 13485 and 21 cfr 820 iso 13485 and 21 cfr 820](http://itcvc.nl/wp-content/uploads/2015/08/certificaten.png)
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.