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 and development process for medical devices follows a “waterfall” diagram as seen below:
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.