This chapter of the standards explains how one medical device company designs, develops, maintains and delivers medical device products. It covers the entire realization processes of the medical device and refers to all phases of the life-cycle of the medical device.

Planning of product realization is the first sub-clause of Product Realization of ISO 13485:2016 standard. The requirements of this sub-clause supposed to go along with the requirements of other processes of the QMS.

The requirements for planning are initiating the master planning of the realization of the medical device and it is referred to the term “quality plan”.

Quality Plan

A Quality plan is a list of activities that one medical device company is obligated to follow or maintain to realize a product according to requirements.

When planning quality, it should include all the relevant requirements and information about the realization of the medical device. It can be seen as sort of a guidebook.

Quality objectives and requirements for the product

The quality objectives are required from top management and it’s achieved by the implementation of a QMS. It should assist the realization of a medical device that meets the requirements that should be described in the quality manual.

Most of the planning of the realization and the determination of the product’s objectives happen through the design and development stages of a medical device. The outputs of the design and development plan shall be used or at least referred to, in the planning of the realization processes.

Processes

The processes are described in the first steps of defining the quality plan. The purpose is to deliver a foundation for the verification process outputs and to allow the medical device manufacturer to test whether the product has been developed according to the plan. The definitions intend to relate to the approaches, techniques, activities, responsibilities, practices, documentation, and specific records that would provide evidence for these processes. The plan may include or refer to documented realization requirements:

• Procedures
• Work instructions
• Routing charts
• Flow charts
• Test instructions
• Diagrams
• Checklists

Regulatory Requirements

Regulatory requirements have a crucial role in the designing stage during the planning product realization. The quality plan will refer to the suitable regulations about several aspects of the medical device. The medical device manufacturer is intended to review the applicable national, local, or international regulation directives or standards that apply to its medical devices and will review whether there are specific requirements regarding the planning of the realization. In the planning of product realization, the following aspects are critical:

• Verification activities
• Validation activities
• Packaging and labeling
• Clinical evaluations
• Examination
• Quality assurance