Explained: Planning according to ISO 13485
Every medical device company must plan while designing and developing their product. The point is to determine a method for development and following it through. While planning, everything from the beginning to the end must be documented. They will document the following, during design and development planning:
- Stages of design and development
- Needed review(s) at each design and development stage
- the verification, validation, and design transfer activities that are appropriate at each design and development stage
- the responsibilities and authorities for design and development
- the methods to ensure traceability of design and development outputs to design and development inputs
- Needed resources, including the necessary competence of personnel
The planning of the design and development has several objectives:
- To identify major design and development tasks
- To divide the design and development into phases
- To eliminate potential quality problems as much as possible
- To allow compliance with regulatory and customer requirements
Control over Related Documents
Updating documents during the design and development phase, it is crucial. All documents have to go through document control. It applies to any documentation platform of the design and development, for example, computer software, instructions, templets, flow-chart diagrams, programs, etc.
Milestones represent the stages that MedDev company must stick to and finish while designing and developing, such as Brainstorming, development planning, inputs, outputs, reviews, etc.
Responsibilities and Authorities
Personnel involved in any of the stages of design and development must have clearly defined responsibilities and activities they need to perform. It includes how they are integrated into the development cycle, to whom they must report, and expected outputs. If necessary, a development team structure with the relation between participants should be included in the definition of responsibilities.
Verification and Validation
The design and development activities must be:
- Verified – the examination that ensures that the development processes are advancing as planned
- Validated – the assurance that results and outputs of the development processes meet the objectives; the test will be with predefined criteria
Internal and External Interfaces
Between the units or groups involved in the design and development stages, the interfaces are important during the processes as a communicative channel. They are responsible for the following:
- Sharing information, data, and knowledge between the members
- The relation between many development plans on different levels of design and development
- Promoting development through the stages
- Ensuring that outputs are verified and suitable for the next phase
Required Training for the Development Team
The training related to design and development has to be identified too. This is covered during the planning of human resource improvement following the requirements of ISO 13485 standard. A medical device company should define in the plan a method for the identification of required training for the design and development process.
Identification of Standard and Regulations requirements
In the plan, MedDev company will identify, indicate, and refer to requirements such as international standards, regulations, or regional directives. These requirements have to be reviewed and specific requirements are going to be included in the activities of the organization.