The process of producing medical device components is very exacting. It is regulated by ISO 13485 as a quality management program that allows companies meeting specific requirements to become certified. This, in turn, allows those companies to actually manufacture the parts under the specifications outlined in the regulations.
These are very exacting specifications that include process wide quality control measures as well as very detailed process analysis and recording. This is critical to ensure that all medical devices offered on the market are safe for use and are not going to have a component failure that could lead to life or death situations for patients.
Design Control
Throughout each step of the design and production of medical device components, there are a variety of design controls that are required. The design controls will vary based on the specific device, and they are more of an outline or a frame that is used to accommodate all components for all medical devices.
It is, therefore, critical for the company manufacturing the medical part or device to work with a machining company that is not just ISO 13485 certified but also a company that understands the key factors involved in this type of documentation and use of the framework outlined in the specifications.
The Stages of Design Control
There are several different sections of stages of the actual framework that the design team, as well as the component manufacturer, have to address. This covers all quality system control requirements throughout the process and provides a consistent type of documentation throughout the process.
For all new medical device components, there will need to be specific documentation developed throughout the stages of:
- Planning the design – this includes plans as well as information on those involved in the design and development.
- Design input – specific procedures used to address the design requirements will be met.
- Design output – ensure the proper functioning of the device will be maintained based on the design input
- Review of the design- establish procedures for formal documentation at specific stages of the design and development
- Verification of the design – developing procedures to verify the device output and input are correct and output will meet input requirements.
- Design validation – define operating conditions and that the user needs will be met, provide a risk analysis if required.
- Designing transfer – ensure that the design is correctly translated into the specifications needed for production
- Design changes – develop a procedure to document, validate, verify, review and approve of all changes before they are used in production.
Additionally, all of the information, including changes made, have to be recorded and available through the design history file.