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There are several stages in the development of a medical device, all of which are subject to strict regulations. In order to be able to develop medical devices safely, there is development control, also known as design control.
What is Design Control?
Design Control reviews the development of a medical device to ensure that it has been developed safely and effectively and meets all required standards.
All Class II and III medical devices and some Class I devices are subject to Design Control guidelines, which in turn are subject to U.S. Food and Drug Administration (FDA) regulations and ISO 13485 standards.
Different Areas of Design Control
The process of developing a medical device through Design Control is divided into nine different steps:
- Design & Development Planning – Development planning is about defining the development activities and systems to be used, and the associated responsibilities. Accordingly, this step establishes the procedures for documentation, review, updating and approval.
- Design Input – The design input step is to define the physical requirements of the device and establish procedures to verify that they are appropriate and meet the intended use of the product. It also clarifies requirements for device functions, performance and safety, reliability, regulatory requirements, human factors and maintenance, among others. It also incorporates initial feedback and resolves any issues that arise.
- Design Output – The Design Output step involves the analysis and evaluation of the development results, i.e. the results of each development phase. This step includes the device itself, but also the packaging and labelling, as well as the main product contacts. The design is also specified. It is important that the design input requirements are met.
- Design Review – The design review is responsible for identifying relevant issues based on documented, comprehensive and systematic reviews. The report must therefore include the representation of all functions involved.
- Design Verification – The design verification phase verifies that the requirements are met against the design deliverables or design input requirements. Verification is confirmed by review and deployment, and the verification itself is finally checked again.
- Design Validation – Design validation deals with the device specifications based on user needs and purpose. Validation is not tested on a prototype, but on a product from the first unit, so that testing takes place under actual or simulated usage conditions. Verification and validation may sound similar, but there is a crucial difference: verification is about whether the device has been designed correctly. Validation is about whether the right device has been validated.
- Design Transfer – The core of design control is the transfer of development from theory to practice. Care must be taken to ensure that all parts are transferred correctly.
- Design Changes – When initiating design changes, it is not enough to just change things; a process must be followed. This includes identification, documentation, validation or, where appropriate, verification, review and approval. New documentation may also be required, depending on the nature of the change.
- Design History File – The final step is to complete the document that summarises the records and aspects of the design history.
What are the requirements?
There are several quality methods and procedures involved in design control.
- A design control software to facilitate the processes and documentation with the aim of minimising the administrative burden.
- During development, each step must be documented to better verify at the end of validation that the product meets all requirements.
- Design control for medical devices is subject to the EU Medical Device Directive. This means that a QM system and detailed documentation are required.
The role of a design control expert is varied and extensive. Much background knowledge of the directives and current legislation is required to ensure that all steps in the development of medical devices are carried out correctly.