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Verification testing proves conformance with documented design outputs and inputs, whereas production testing determines whether the unit being tested has been manufactured correctly. Production testing is rarely comprehensive enough to verify the design. Design control is not a “once and done” process – it applies to modifications or improvements to existing designs, or changes to processes.
Setting the Stage with Design Reviews
This project will be used to evaluate the process, the methods, and the procedures that the firm has established to implement the requirements for design controls. About 20 years later FDA has followed this up with a guideline concerning the implementation of the legislation. Around the same time the ISO was created (based on ISO 9001) due to similar reasons.
Institutional Review Board Statement
So, you have an idea for a medical device, and you obviously want to take it to the market so that it can have a positive impact on tons of people’s lives and maybe make you a little money as well. Confirm that changes were controlled including validation or where appropriate verification. For existing DaVinci Resolve users, the Micro Color Panel offers a familiar feel.
Design Verification and Validation
The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part. Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications. Your design verification records need to include the date and person who performed the verification as well as methods, acceptance criteria, and any statistical techniques used. The US FDA likes to see these activities displayed in a traceability matrix. Risk management is a critical part of regulatory compliance and has a direct link to design control.
What Is a Medical Device Master Record (DMR)?
Completing Design Validation is an important step in closing the loop on your traceability matrix too. The traceability matrix started with User Needs and ends with Design Validation. If you have been keeping your Design Controls traceability matrix up to date, you have a clear picture of the relationship between your Design Inputs and Design Outputs.
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The goal of this Design Transfer Design Review is to make sure everything that is needed for production is ready and done. The end goal of Design Validation is to have objective, documented evidence. If you remember the discussion about User Needs, I shared that sometimes User Needs have a tendency to be a little ambiguous, using words like “easy” and “better”.
Medical Device Design Control Planning
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This is true for both new developments or changes to existing products. FDA regulations for medical devices are strict, complex and lengthy. Here’s a plain and simple version of design controls for medical device development to help you understand FDA design controls for medical devices. Plus best practices for implementing design controls as productively as possible. Outputs must be comprehensive enough to characterize the device design to allow for verification and validation. Also, design outputs which are essential for the proper functioning of the device must be identified.
Good Design Controls Reduce Product Risks
It is important to note that Design Controls start with the approval of the design inputs. If a new idea for a medical device is conceived it is beneficial to have a research / concept phase to evaluate technical feasibility. After the company has decided to pursue the project and provides the required funds, resources and staff, Design Controls should start.
Defining how to make your medical device through Design Outputs
Design outputs are the work products or deliverables of a design stage. Examples include, diagrams, drawings, specifications and procedures. The outputs from one stage may become inputs to the next stage. The total finished design output consists of the device, its packaging and labeling, and the device master record. Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation. The focus of design control is predominantly centered around the type of device, software used, materials required, and manufacturing process.
Organisations will have a central repository to create, modify, review, approve, store, organize, access and share documents globally in a controlled manner. Create, schedule, and manage audit programs using the calendar view available in the CQ Audit Management Software. The software also facilitates collaboration between stakeholders during the different stages of an audit and helps the enterprise build a QMS workflow that is data-driven and enables Continuous Improvement (CI).
CQ CAPA management solution uses predictive analytics and intelligence to identify the right issues to solve. The solution supports various methodologies like 8D, 5W-2H, and World Class Manufacturing (WCM). As for timing, the design validation is completed after clinical evaluation is complete. Your clinical evaluation may include a clinical trial but is more likely to consist of safety testing, literature searches, etc. Also, regulators know that it is not always practical to perform clinical studies on finished products, so you are allowed to use prototypes.
Medical device product development should follow a structured, methodical approach with traceability throughout. This is significant because up until this point the “control” of the medical device has been the responsibility of the project team. Once Design Transfer occurs, the control shifts to production resources. As you get into the hands-on, nitty-gritty design and development, you start to identify all the parts and pieces that are required for your medical device. Demonstrating traceability of all your Design Controls throughout the product development process is expected and required.
This is your complete guide to understanding just what Design Controls really means for your medical device product development. If you enjoyed this article, check out our intensive medical device design control training class. Also, if you’re not sure where to start with implementing design controls in your company, we can help. All of these inputs must be documented, reviewed, and approved for adequacy, and you need to make sure that the requirements are complete, clear, and don’t conflict with one another. Basically, design inputs should specify what the design is intended to do but they should avoid specific design solutions. Your product developers play a key role (but not the only one) in developing the design input requirements, regardless of who developed the initial product concept.
