What are Design Controls?
Design controls are a set of processes and procedures that medical device manufacturers must follow to ensure that their products are safe and effective for their intended use. Design controls are a requirement of the U.S. Food and Drug Administration (FDA) and are used to establish and maintain the design of a medical device throughout its life cycle.
Design Controls Process
The design controls process includes several phases, including:
User Needs: Identifying the needs of the end-user and the intended use of the device.
Design Input: Defining the design requirements for the device, such as its performance specifications and acceptance criteria.
Design Output: The development of the device’s design, including its specifications, drawings, and other documentation.
Design Verification: Testing and evaluating the device to ensure that it meets the design requirements and specifications.
Design Validation: Testing the device in its intended environment and use conditions to ensure that it is safe and effective for its intended use.
Design Transfer: Transferring the design of the device from the development stage to the manufacturing stage.
Design Changes: Managing and documenting any changes made to the device’s design throughout its life cycle.
What is a Design History File and Why is it Important?
A Design History File (DHF) is a collection of documents and records that provide a complete history of the device’s design and development. The DHF is an important tool for demonstrating compliance with the FDA’s design control requirements and should include all documentation related to the device’s design, testing, and production.
Do I Need to Use Design Controls for My Medical Device?
Design controls are required for all medical devices, regardless of their classification (Class I, II, III). However, the level of rigor and documentation required will vary depending on the device’s classification and the level of risk associated with it. Class III devices, which are considered high-risk, will require the most extensive documentation and testing.
| Class I | Class II | Class III |
| Minimal documentation and testing requirements | Moderate documentation and testing requirements | Extensive documentation and testing requirements |
| Examples include simple devices such as bandages and elastic bandages | Examples include devices such as powered wheelchairs and surgical drapes | Examples include devices such as implantable pacemakers and heart valves |
| Generally considered low-risk | Generally considered moderate-risk | Generally considered high-risk |
Why Choose Innovenn?
At Innovenn, our team of experts has the experience and knowledge to guide you through the complex design control process. With over 250 years of collective experience, our team has the skills and resources to help you develop a medical device that is safe and effective for its intended use. We understand the importance of getting your device to market as quickly and efficiently as possible and work closely with you to support a submission that is complete, accurate, and meets all FDA requirements. By choosing Innovenn for your design control needs, you can have peace of mind knowing you have a team dedicated to developing a device that is in compliance with FDA regulations and ready for market.
Conclusion
In summary, Design controls are a set of processes and procedures that medical device manufacturers must follow to ensure that their products are safe and effective for their intended use. Design controls process includes several phases like User Needs, Design Input, Design Output, Design Verification, Design Validation, Design Transfer, Design Changes. Design History File (DHF) is a collection of documents and records that provide a complete history of the device’s design and development. It is important for demonstrating compliance with the FDA’s design control requirements. Design controls are required by the U.S. Food and Drug Administration (FDA) or all medical devices, regardless of their classification. Other countries do require similar requirements and typically follow ISO13485.
FAQs
Do I need to have a Design History File for my Class I medical device?
Yes, a Design History File is required for all medical devices regardless of their classification.
What is the difference between Design Verification and Design Validation?
Design Verification is the process of testing and evaluating the device to ensure that it meets the design requirements and specifications. Design Validation is the process of testing the device in its intended environment and use conditions to ensure that it is safe and effective and meets the intended use.
How long does the design control process take?
The length of the design control process can vary depending on the complexity of the device and the quality of the data and information submitted.
Can I outsource the design control process?
Yes, manufacturers can choose to outsource some or all of the design control process to a third-party consultant or service provider. It is important to ensure that the provider is experienced and knowledgeable in the design control process and FDA regulations. A detailed Design and Development Plan will need to be established describing roles and responsibilities through out the development of the product.
How often should I review and update my Design History File?
The frequency of review and update of Design History File should be based on the product/project specific plans outlined by the manufacturer dictated by the Quality Management System. It is important to ensure that the DHF is up-to-date and includes all relevant information about the design and development of the device throughout its life cycle.
