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