Since the Safe Medical Devices Act of 1990, the Food and Drug Administration (FDA) has had strict regulations for the design of Quality Management System (QMS). Design Control refers to the design of devices, along with processes and changes to existing designs and processes.
The design control requirements of the FDA’s regulations are enforced upon the design of Class II and III medical devices, along with some Class I devices, according to BoneZonePub. As the publication notes, this design control regulation “gives manufacturers just enough rope to hang themselves.” Given the different risks and complexities that come with various medical devices, companies are given the responsibility of deciding the type of design control system and the detailed implementation instructions used for their devices.
BoneZonePub claims that the following get a great deal of attention during inspection:
- “Design and development planning versus what information ends up in the design history file
- Identifying design inputs and then the essential outputs
- Verification work that could eventually end up in the design history file as a formal acceptance activity
- Validating the design from a standpoint of the intended use and user needs
- Controlling design changes before and after commercialization
- Reviewing design results versus the original design plan
- Transferring the design to production while realizing the value of concurrent engineering
- Compiling a Design History File as a basis for the Device Master Record”
Medical manufacturers take on tremendous responsibility in creating medical devices. The FDA’s Design Control regulations are one of the efforts made to ensure that medical products are of the best quality.