What are Design Controls and why do they matter in Medical Device Development?

Although they differ in finer detail, both the European and U.S. regulatory laws discuss Design Controls.

Failure to comply with these laws can result in a series of penalties including your device being taken off the market…

Design Controls give structure to the Medical Device Design & Development process. While they allow some innovation, they ensure you are meeting all of the products (and users) indented needs without being lead astray. They ensure designs remain feasible and allow for full traceability. Ultimately, Design Controls demonstrate that your medical device is safe, effective, and meets the indications for use. Not to forget that they also focus on ensuring that you will actually be able to manufacture the device as intended.

One of the first steps is to establish a quality system. This system, consists of a number of processes and procedures that you define and implement to describe your process for addressing medical device regulations – one of which being Design Controls.

Applying Design Controls is not a singular activity. It is an accumulation of thorough planning, executing, and documenting throughout the process. Usually, Design Controls will start with capturing user needs to define Intended Use Statements/Claims. These claims, are then used to define the projects design inputs which guide the design process and, ultimately, generate design outputs (examples of these include drawings, specifications & instructions – essentially everything you need to manufacture and assemble the device) that address all user needs.

We strongly recommend keeping all relevant documentation up to date throughout the project. At HD, we use a number of quality management systems, processes and software to bring all of this information together and more recently, have implemented Aligned Elements (traceability software) to further strengthen our certified Medical Device Design & Development Process.

Of course, the design process is iterative, therefore many of these files consist of living documents. It is important to have a robust Change Control process in place. A Design History File is a record where all changes throughout a project are maintained. Although it may be tempting to leave it until the end, believe us, it isn’t pleasant! You can use tools such as a Design Controls Traceability Matrix to help with this.

Ultimately, Design Verification is about proving that your Design Outputs meet the Design Inputs. Of course, the Design Controls and wider Medical Device Development process certainly isn’t light and there is more to it than discussed. At HD, we understand the burden of compliance and that it can bog a project down. During device development for volume manufacture, full Design Controls are applied within our formal device development process. This ensures projects are properly managed and provide evidence for MDR and FDA compliance. If you would like to learn more about or discuss how Haughton Design can help with your Medical Device Development, please get in touch.