1.1. Design Project Plan
The Design Project Plan identifies and describes the specific plan for the design and development activities to be performed including a proposed timeline with projected milestones. The plan includes proposed quality practices, assessment methodology, record-keeping and documentation requirements, an assessment of resource requirements, an assessment of the acceptable risk/benefit for the specific design and a formal timeline or sequence of events related to the particular design or design category. The plan may also include regulatory strategies for the specified countries and projected market release dates.
Includes defining roles, responsibilities, and accountability for each team member throughout the product lifecycle.
The Design Control Process manages the development and transfer of new medical device products and design changes to existing medical devices for product release to market. The Design Control Process is initiated when technical feasibility of a design/solution has been determined. The Design Control Process applies to the entire device development process from project initiation through to the release of production specification(s) and product release to market.
A documented formal approval of the design results associated to a phase of the design process.
Determining what standards are applicable to a particular medical device.