Design control in medical devices ensures that a device is suitable for its intended use by incorporating a set of quality practices and processes into the product design and development process. Read this article to find important pieces of the design control process, tools as well as a summary of the knowledge.
Paweł Zieliński – Marketing Manager Consonance
What are design controls?
An organized design and development process for medical devices is facilitated by design controls, which are procedures mandated by regulatory organizations. The design control goal is to regulate the design process and ensure that devices satisfy user needs, planned applications, and predetermined specifications. It is possible to ensure that designs will be created that will satisfy user needs, intended uses, and requirements by paying attention to design and development planning, identifying design inputs, developing design outputs, verifying that design outputs meet design inputs, validating the design, controlling design changes, reviewing design results, transferring the design to production, and compiling a design history file.
Design controls standards and regulations
Is the medical innovation journey made harder by this? How does this affect medical device design services? When employees learn about new developments, they frequently wonder whether adding more structure would burden a firm more.
The fact is that these standards will make life simpler if a firm is creating and producing quality products. This may be especially true for smaller businesses. For instance, a small medical device firm can find it challenging to compete directly with a larger one that has more resources. The area where they can face off against one other is in standards and regulations.
The initial goal of ISO 13485 was to assist businesses in establishing a QMS that would allow them to demonstrate that they are creating products as intended and that they have oversight over both their R&D and production processes. They will ultimately create a good—not a bad—product.
The new standard ISO 13485:2016 offers guidance about design controls. It’s essential to keep in mind that the manufacturer of medical devices is accountable for product quality regardless of whether a variation or error originated with the supplier or inside the organization itself.
Standards like ISO 13485 balance the level of competition among major corporations and small businesses since everyone is compelled to produce high-quality goods. Companies that use lean and agile business models may concentrate on launching products that are on par with those of larger, more resource-rich firms.
Medical device design control process
Planning, design execution, testing against inputs and requirements, finding and resolving issues early on, and planning are the main components of design control (risk reduction). All pieces are set to discover needs and manage projects and potential risks which might happen. So let’s dig deeper to find important phases:
User needs Phase
The initial phase of design control is the user needs phase. The intended application and use guidelines for the proposed medical device must be determined by your team. The goal is to use the new medical equipment as designed. This refers to the gadget’s overall function.
The disease or diseases that the proposed medical device would diagnose, treat, prevent, or mitigate should be described in the indications for use, on the other hand. You must also specify the possible patient base for which your medical device is authorized at this phase.
Design and Development Planning
The design and development planning stage is the next step in Design Controls. Your team will need to create a plan to get the Design Controls process started that will show design and development activities, emphasize implementation roles, and provide methods for evaluating, documenting, updating, and approving plans as this phase develops.
Design Input Phase
Your team will need to detail the precise specs of your suggested medical gadget during this Design Controls step. You must be clear on the function and functionality of the equipment.
Design Output Phase
Your team will detail the precise requirements for the new medical device during this stage of the design controls process. What anticipated materials and parts are required to construct the new device?
During the design output process, inquiries like the one above are addressed. You must use a Design Controls Traceability Matrix to demonstrate the link between design outputs and design inputs as you construct them (Phase 3). Microsoft Excel may be used to analyze the links between design inputs and design outputs. At the start of the development process, this is feasible. But keep in mind that later on, things might get rather complicated.
You should create the Device Master Record, which is another thing to keep in mind throughout the Design Output Phase (DMR).
The DMR will include all the details and requirements required to manufacture a medical device from beginning to end. Additionally, it will have criteria for labeling and packing as well as directions for the whole production process.
Design Review Phase
Formal design evaluations will need to be carried out and validated by a team. You will have the chance to assess the design specifications of your new medical device during these phases of the design review process. You can be sure that your gadget is on the right track.
Design Verification Phase
Your team will test the new medical equipment in various ways throughout this Design Controls phase to ensure that it has been created correctly. Simply, you are making sure that your medical innovation is operating as it should.
Design Validation Phase
This stage signifies that your medical gadget complies with the intended usage and the demands of the user. Instead of employing prototypes, early production units, batches, or lots are used for design validation.
Design Transfer Phase
At this point, your medical device will really begin to be produced. You must make sure that the production team receives accurate transfer of all design information to guarantee smooth manufacturing of the medical device.
Design Changes Phase
The Design Changes Phase kicks off when a medical device’s original design is altered in any way. Let’s imagine that you need to modify the manufacturing process for your medical innovation. The Design Changes Phase’s adequate document management and change control procedures make this feasible.
How does QMS improve the medical device design control process?
One procedure that has to be included in the quality management system (QMS) is design controls. Design Controls connect those elements with extra development-specific processes, and your QMS should also have policies in place to handle papers, records, and suppliers. Beyond building and testing a medical device, the design and development process is governed by Design Controls. A few of the QMS procedures that directly influence design controls include producing paperwork, making sure suppliers are suitably qualified for their roles in the manufacturing process, and keeping records.