Can Test Method Validation For Medical Devices Be Outsourced?

Throughout every medical device manufacturing stage, there is a set of critical parameters that are closely monitored in order for the final product to be up to specifications. Any such tests being conducted during the production stages are called In Process Controls (IPC), while tests conducted out of the manufacturing floor are done as part of Quality Control (QC). In this article we take an in depth look into what factors to consider when determining critical parameters and medical device testing methods.

In Process Medical Device Testing

During any manufacturing process, there are a number of factors that can highly influence the final outcome of each production stage. In industrial manufacturing, these factors are called critical parameters and they must be adequately monitored to ensure a high final product quality. Here are the key factors to consider for medical device manufacturing:

• Manufacturing Stage: Critical parameters are different for each production stage. This provides a clear view of where to pay attention during every manufacturing operation.
• Working Thresholds: In the real world, there are no absolutes. Nothing is eg. absolutely square, straight, of a certain length, or color. So it’s important to control this variability, by setting min and max limits for every critical parameter. This makes sure every manufacturing stage is kept within allowable working thresholds.
• Sampling Levels: Depending on the case, there are parameters you have to monitor at 100% of the produced pieces. In an adequate sample of the produced pieces according to a sampling scheme (eg. check 10 pieces for every 500 produced). This has to do with how critical of a parameter is being monitored, as well as with device and manufacturing limitations.
• Corrective Actions: For every critical parameter, it should be clear what corrective actions to conduct in case an out of spec finding occurs.

Determining Critical Medical Device Testing Methods

Your testing method should be determined for monitoring every critical parameter, according to the following considerations:

• Sampling Levels: A parameter’s testing frequency is a determining factor on what testing method to use. The higher the frequency, the testing method needs to be more time-efficient, cost-efficient, and easy to conduct.
• Destructive Or Non-Destructive: Both may be used, with non-destructive testing methods being especially preferred when high sample sizes are required. Needless to say that for 100% testing, destructive testing methods cannot be used.
• Test Grouping: It makes economic sense to select testing methods that can group together measuring of many critical parameters in one test.
• Speed & Efficiency: IPC testing should not delay or stall manufacturing operations, or at the very least such effects should be kept to a minimum.

Testing Equipment Calibration

It goes without saying, that medical device IPC or QC testing requires properly calibrated testing equipment. It’s important to ensure that inspection, measuring, and testing equipment is capable of producing valid results. So there should be calibration procedures in place, with specific instructions, limits for accuracy, and precision. These calibration procedures of course need to be traceable and include records with equipment ID, dates, persons responsible, upcoming calibration dates, and proper equipment labeling. 

Documenting Test Results

Documenting critical parameters for measuring results provides a treasure trove of data that can be mined to gain insights into your product’s manufacturing. This data is also the basis for statistical analysis, improvement, and excellence systems such as Six Sigma, Kaizen, and Total Quality Management (TQM). Also, proper documentation provides better tracking and traceability, enabling you to pinpoint precisely where and what to improve in the future.

Gain Confidence & Peace of Mind

Medical device test method validation must be taken very seriously. In cases of product recalls and negative financial impacts, this part of the process will be of top priority for examination.

At Quasar we strive to provide companies like yours with the peace of mind, that your devices are always properly monitored and tested. Contact us to discover how we can help you focus on your core business, and gain the confidence of being able to deliver your clients with medical devices on time and up to specifications.