In this article we will review the additional requirements for Design and development (chapter 7.3) as specified by the ISO 13485 Standard with reference to the ISO 9001 Standard. Get ready for a long exhausting journey through the world of developing products under the ISO 13485 Standard supervision…

The ISO 13485 Standard's (as well as the ISO 9001 Standard's) bottom line is: determine a method for your development and follow it (say what you do and do what you say…). The main goal is to eliminate potential problems as much as possible. The tactic is to examine whether the development is preceded within measured steps according to prior requirements; regulatory and customers', and according to prior planning.
The method for design development should regard the next issues:

• Mile stones during the development process: the stages that the organization must follow through, while performing any kind of design and development. Your organization is required to describe what the development activities are. It is required to define what is expected at the end of any activity – the outputs.
• Definition of responsibilities and authorities during the design and development. Very similar to organizational definitions. Who is doing what, when and to who he must report.  The purpose is to submit the process of developing medical devices into a control.
• The method should include where time frames, schedules, objectives and resources are decided and documented. The specifications must refer to purchasing of any kind, as well. All the parameters that affect the development.
• The method must allow identification of any requirements for the development: Standards requirements, customers' requirement and off course regulatory requirements.
• The method shall include how the organization verifies and validates that the development proceeds according to the defined requirements and who are the responsibility parties. The planning must allow an effective control over the design and the development. In other words, how one can examine whether the development was conducted according to the plan.
• The planning must include specifications of internal or external interfaces and information sharing. When there are different plans from different parties within the organization or outside the organization – the plans must be related to each other.
• In addition, the method shall verify and validate the transfer activities between the different development stages. The purpose is to ensure that the outputs after any milestone of the design and the development would be verified and validated.
• Risks – you are required to define a method to identify risks before and during the development processes. The method should refer, to any kind of problems that might arise during the development. The method should also define under whose responsibility, any risk or problem may occurred, for example a department or a specific function.

So far the ISO 9001 Standard and the ISO 13485 Standard requires the same. Until now. The ISO 13485 Standard requires a documented procedure describing the process of design and development within the organization.  While the ISO 9001 Standard requires to determine a method but not to document it, his cousin, the ISO 13485 Standard, requires a documented procedure. The procedure must include all the requirements mentioned in the table above.

Second additional requirement regards the internal or external interfaces and information sharing during the design and the development. As mentioned, the purpose is to ensure that the outputs after any milestone of the design and the development would be verified and validated. The 134985 explains it as a control given to the outputs before they are submitted to manufacturing. I tend to agree on that one. As an external advisor to many software development companies, many times information between various departments somehow fails to flow. Such definition would solve the problem.

Third additional (and quite natural) requirement is that any update within any documentation regarding the design and the development, would be under the documents control method within the organization.  That means that you must include the design and the development procedures and documents under your documents control procedure. Plan your design and development plan according to the method of documents control. This requirement usually regards the edition of documents. The update of documents is crucial under the design and the development theme.