Medical device component manufacturers are held to high standards, most notably the guidelines set forth by the Good Manufacturing Practices for finished pharmaceuticals and medical devices. These guidelines require four separate process validations that all medical device component manufacturers must follow. To help you get a better feel for the standards medical device component manufacturers adhere to, here are the four process validations that should always be followed in order for you to receive the exact medical device components and accessories that you need for your medical device.
If a facility has never been validated before, retrospective validation will be the first validation to take place. During a retrospective validation, documents and historical data are analyzed in order to provide a retrospective analysis of an operation's procedures, process controls, and facilities. Today, retrospective validations are rarely performed since there are few facilities which have not undergone validations before. However, retrospective validation is still used if a process that has been previously validated is being audited, so it is still a validation that medical device component manufacturers should be prepared for.
Prospective validation, also known as premarket validation, takes place before the manufacturing of a new device begins. During a prospective validation, documents are submitted outlining the manufacturing process and showing that all of the correct systems and procedures are in place. Once a prospective validation has taken place, manufacturing of medical compenents can typically begin.
During a new device's first production run, concurrent validation is conducted throughout the production process to ensure that all requirements and standards are being met. Crucial steps in the production are closely monitored, and once the device is finished, it is thoroughly examined and tested.
While prospective validation ensures that everything works well in theory, concurrent validation ensures that everything works well in practice, monitoring a medical device's production in real time to guarantee that all processes are functioning as intended.
In order to maintain compliance throughout the production of a medical device, revalidation is a necessary process. Revalidation entails the repetition of the various other validation processes listed above, as well as a comprehensive review of all available data. Though it is standard to perform revalidation periodically, there are other things that can trigger a need for revalidation such as changes in the way the product is produced and changes to the product itself.
By following these four validation processes, medical device component manufacturers are able to ensure that they remain compliant with all necessary requirements and produce a device that is 100% safe and effective.
At Hartford Technologies, these four validation processes are central to everything we do regarding the production of our components for medical devices, and they should be equally central to anyone who uses our components in the design of their medical device. If you would like to learn more about how we can help you produce a medical device that will live up to these validations and be completely safe and effective, contact us today.