Developing a new medical device from concept to market can be a complex process. Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process (i.e., a system of checks and balances) for a medical device. Design controls make systematic assessment of the design an integral part of development. As a result, deficiencies in design input requirements, and discrepancies between the proposed designs and requirements, are made evident and corrected earlier in the development process. Design controls increase the likelihood that the design transferred to production will translate into a device that is appropriate for its intended use. It should be noted that most Class I medical devices in the United States are exempt from following design controls and are subject only to general controls.
The design control process does not end at the transfer of a design to production; evolutionary changes will occur due to corrective actions resulting from post-market surveillance and continuous improvement efforts.
Kymanox has the expertise to help manage design controls to successfully drive your medical device from concept to market and beyond. Similar approaches are followed in other highly regulated regions outside of the United States, such as Canada, Europe, and Japan. No matter which region our clients need support within, Kymanox focuses on providing clear documentation of the entire process in compliance with all applicable regulatory statutes and industry standards.
In the United States, the Food and Drug Administration (FDA) has required that medical device manufacturers follow the Design Control requirements (21 CFR 820.30) if they want to market certain types of medical devices. Below is a summary of the FDA requirements for design controls established in section 820.30:
- User needs and an understanding of how the customer will use the device must be documented.
- Design inputs must be established and the proper functioning and performance of the device must be understood.
- Acceptance criteria must be established prior to performance of design verification and design validation activities.
- For design verification, the design outputs must be shown to meet the design input requirements.
- For design validation, the approved design must meet the predetermined user needs and intended uses.
- If applicable, software that is part of the medical device must be validated.
- Risk analysis must be performed throughout the design and development process.
- Design reviews must be conducted and the design must be correctly transferred to production.
- All changes must be evaluated for their impact on design verification and validation. Performance of new studies may be necessary.
Similar requirements are in place in other regions of the world, such as Europe, Canada, and Japan. Kymanox uses the appropriate regulatory requirements when working with a client to ensure the necessary activities applicable to the medical device are completed and documented effectively.