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...and devices that are safe and effective with something like an automated pre-shipment screening process or third-party inspection regime and then audit that process off line (after entry), it could use its precious HumINT and inspection resources on demonstrably higher-risk shipments or true unknowns...

...such as good manufacturing practices (GMPs), allowing third-party certification instead of requiring direct MHLW approval, and developing a market authorization holder (MAH) system. Today, application forms and certification processes for IVD products differ slightly from other medical devices...

In the complex world of biological vaccine manufacturing, anything that has a direct impact on SISQP must come under documented and/or validated quality control protocols and procedures. These quality requirements are audited by the company and at times by third-party consultants, as well as by CBER, the FDA 's...

...gaps in its understanding of the issues, but they appear to have realized that, as a third party, we had a different perspective than an operating pharma company. We offered some middle ground. We re trying to raise issues that are important to helping the industry understand the underpinnings...

...contamination, contrast media residuals, and packaging defects were observed among reprocessed catheters taken from German hospitals, reported Schr oer. As for 10 single-use biopsy forceps reprocessed by third-party companies...

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