Before any new medical device can be brought to market, the FDA and other health authorities require the device meets production standards specified both by the design and by device registration regulators. But, testing every single device that we manufacture at Quasar is not only impractical—in many cases, the testing itself would render finished devices unusable.
Instead, we use a process validation to ensure the quality of every device we produce. Process validation tests the process for manufacturing devices rather than the finished and produced devices themselves. By ensuring that the manufacturing process is valid and stable, we can be sure that any medical devices produced will be up to quality standards and per its specifications.
In this article, we discuss four main points of focus of our validation process for manufacturing any new medical device.
The first thing we do to ensure a consistent process is to specify and define every piece of equipment used to manufacture a device. Changing from one part to another on a key piece of manufacturing equipment can substantially change production specifications. equipment bill of materials and components definition gives our technicians the information they need to contact the right manufacturer for an existing part and the specifications needed to get exactly the same part.
While this may seem like a small detail, gathering the bill of material and components definition is required to make sure that there are no unanticipated changes to a device’s manufacturing process or specifications. So, it is an important component of process validation for medical devices.
Assembly is a crucial part of the manufacturing process where variation between devices can be introduced if proper care is not taken from the start. We intensely scrutinize the assembly instructions for each stage of the manufacturing process to identify and resolve ambiguities or potential points of variance.
In addition, we ensure that all employees responsible for device assembly are thoroughly trained on the tasks for which they are responsible. This training is documented and technicians are encouraged to use visual process controls to ensure that each assembly step is performed properly.
Importantly, we also account for final process validation results during the design stage. First, we ensure that the equipment, as designed, will meet both its intended purpose and its intended use.
Second, when possible, we incorporate verification points into the equipment design. These verification points may make it easier, for example, for technicians to visually or physically verify an assembly stage.
We make sure that our protocols for process validation for a specific manufacturing process and for the overall process are written down and reported. Just as definitions and specifications ensure that our manufacturing process is consistent, written protocols ensure that our process validation is consistent across technicians and over the entire life of a manufacturing process.
In medical device manufacturing, process validation is a crucial step for meeting FDA and international standards. While there can be numerous aspects to consider in the validating process, we at Quasar prioritize these four aspects. This is what gives us and our partners the confidence of absolute accuracy, safety, and consistency for every medical device we produce. Contact us today to discuss your medical device production needs.
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