The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system.

The organization shall document one or more processes for risk management in product realization. Records of risk management activities shall be maintained (see ISO 13485 §4.2.5).

In planning product realization, the organization shall determine the following, as appropriate:

1. quality objectives and requirements for the product;
2. the need to establish processes and documents (see ISO 13485 §4.2.4) and to provide resources specific to the product, including infrastructure and work environment;
3. required verification, validation, monitoring, measurement, inspection and test, handling, storage, distribution and traceability activities specific to the product together with the criteria for product acceptance;
4. records needed to provide evidence that the realization processes and resulting product meet requirements (see ISO 13485 §4.2.5).

The output of this planning shall be documented in a form suitable for the organization’s method of operations.

What should be included in the design and development plan?

• Write it down.  Create a plan that allows agreement on all the quality processes that will be employed during the entire lifecycle of the product.  Write down what you do know in the plan, and identify the areas with unknowns that will be researched and updated as part of the lifecycle of the product.  Use the 80/20 rule – don’t get hung up on the 20% you don’t know – release the plan.  Then update the plan as more is learned.
• Interfaces between groups – except for the smallest manufacturers, generally many different groups will work together to design, develop, verify, validate, manufacture, service, and monitoring a medical device.  The design and development plan is the place to describe how the groups responsible for all those disparate functions will interface/interact/communicate, and at what points in the lifecycle will these interactions will occur.
• Identify the activities that will occur at each lifecycle phase and what deliverables will be produced.

A common design and development plan outline from various industries follows:

1. Introduction
   1. Project Overview
   2. Project Deliverables
   3. Evolution of the SPMP
   4. Reference Materials
   5. Definitions and Acronyms
2. Project Organization
   1. Process Model
   2. Organizational Structure
   3. Organizational Boundaries and Interfaces
   4. Project Responsibilities
3. Managerial Process
   1. Management Objectives and Priorities
   2. Assumptions, Dependencies, and Constraints
   3. Risk Management
   4. Monitoring and Controlling Mechanisms
   5. Staffing Plan
4. Technical Process
   1. Methods, Tools, and Techniques
   2. Software Documentation
   3. Project Support Functions
5. Work Packages, Schedule, and Budget
   1. Work Packages
   2. Dependencies
   3. Resource Requirements
   4. Budget and Resource Allocation
   5. Schedule