Design Control (verification & validation)
For the end user's safety and to place the Medical Innovation on the market, a manufacturer has a legal obligation to maintain design control and files associated with this process.
What are Design Controls in medical devices?
Regulatory agencies want assurances that medical devices are safe and efficacious.
Design controls prove that medical devices will serve their purpose and will meet end-user needs and requirements.
What medical devices need to be brought under Design Controls?
Class II and Class III medical devices such as X-ray machines, surgical needles and implantable medical devices have design control requirements.
The process of Design Control is divided into various phases.
The phases of Design Control are:
- User Needs Phase
- Design Input Phase
- Design Output Phase
- Design Review Phase
- Design Verification Phase
- Design Validation Phase
- Design History File
Identifying, defining, and adequately documenting users' needs are crucial.
First, it identifies the process for designing and developing the medical product, ensuring that it is as efficient and effective as possible.
Identifying user needs also enhances the quality and performance of the ultimately developed product and facilitates the approval process.
Once all the user needs are identified, it's time to figure out the design inputs, which will determine the overall design.
Design inputs can be identified from:
- Industry standards
- Guidance documents
- Risk analysis
Design outputs show that the design inputs have been applied.
These documents serve as guidance for the production and assembly of future products.
Design outputs will include records such as:
- Manufacturing plan and instructions
- Component specification
- Production and assembly instructions
A Design History File (DHF) stores all documentation related to design controls; it also indicates the design history of a medical device. A Design History File is used to provide evidence that all design control procedures were correctly implemented and followed.
Design History File (DHF) is an important document that details all steps taken during the design of Maininting a DHF is a mandatory requirement for regulatory agencies (for instance, FDA 21 CFR 820 and ISO 13486).
Manufacturers often misinterpret the requirements of Design Verification and Design Validation. It is essential to understand the difference.
Design Verification vs. Design Validation: What is the Difference?
The design verification process is used to ensure that the design outputs meet specific requirements. A variety of test methods can be applied depending on the aspect of the device being evaluated.
Several types of physical testing can be done, including mechanical or electrical benchtop tests, benchtop tests using biological tissues, preclinical evaluations, etc.
Validating a product's design ensures that it meets identified user needs. This can be done through usability studies, short or long preclinical studies, or clinical trials. Before a clinical trial can begin, all other tests must be completed and submitted to a regulatory agency for approval (Notified body). These studies typically evaluate user interaction with the device or its comprehensive functional performance.
Design verification demonstrates that your design outputs (the medical device product you have designed) match the design inputs (which you determine through the definition of user needs).
The design verification process can be a complex one. Testing is often a big part, but visual inspections and analyses also play an essential role. Good documentation helps ensure the design verification process goes smoothly.
You can ensure that you have created the right product by validating your design.
When designing a medical device, one of the first things you must do is define:
- The medical device product's purpose
- What the medical device does
- The diseases, conditions, and circumstances under which the product will be used
- The type of patient who would benefit from the device
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