One of the leading causes for medical devices recalls is the lack of control engineering and design processes. As a result, medical device design controls procedures were added to the GMP regulations.
Design controls are a set of interconnected practices and procedures built into the medical device design and development processes. Design controls increase the likelihood that the design will be translated into a product exactly as intended.
In order to begin the medical device design control process it is necessary to create a plan .Development planning includes systems that describe or relate to development activities, define implementation responsibilities, identify and describe interfaces to different groups, and also include procedures for reviewing, documenting, updating, and approving plans as design and development evolve.
Design input refers to both the physical and performance requirements that will be used as the basis for the device design. In addition, a number of procedures must be established and maintained to this end. These procedures must ensure that the requirements are reasonable and in line with the product’s intended purpose. Device design must also address, document, review, and approve incomplete, ambiguous, or conflicting requirements. Design input sources are the application specification, including:
There are several examples of design and development inputs, such as device feature requirements, physical properties, performance, safety, reliability, environmental limits, sterilization, standards, regulatory requirements, labeling and packaging requirements, maintenance, or compatibility with others.
Design output refers to the development results in each development phase and at the end of the entire project. The design output (AKA development results) in its complete form consist of:
This means that design outputs must illustrate the design specification and meet the input design requirements. This is confirmed by design verification and validation stages.
The development evaluation must be a documented, comprehensive and systematic review. It should assess the adequacy of the development requirements, the ability to meet them, and identify problems. In addition, any development review must include an appropriate account of all relevant functions
Design Verification (AKA development results) describes the process of ensuring by examining and providing objective evidence. It indicates that the specified requirements are met. In addition, it is confirmed that the development results meet the requirements of the design Input. Design verification is also reviewed, approved and documented in the Design History File.
In contrast to development verification, design validation shows that the device specifications correspond to the user needs and the intended purpose. This is proven by objective evidence. The development validation must be carried out under defined operating conditions, under actual or simulated operating conditions.
It can be seen that delegating is a core principle of the medical device design control process. To do this, it is necessary to have a detailed plan and to implement it consistently. This plan must ensure that all the design parts are transferred correctly so that the device can be manufactured without problems.
Finally, the product pilot series can be released for production. Appropriate procedures are required at this step. Ultimately, it is very important that all results are communicated appropriately to the manufacturers and suppliers. The results of the activities are brought together in the main product file (Device Master Record / DMR).
Before any development changes are made, several procedures must take place. This includes identifying, documenting, validating or, where appropriate, verifying, reviewing and approving device development change procedures.
Depending the change scope, new regulatory documents may be required based on the requirements of the competent authority. It is very important that the changes are communicated to the FDA or other relevant competent authorities properly.
