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By Allan Marinelli and Howard Mann | All drug delivery manufacturing systems undergoing quality improvement projects involve teams to gather many inputs and then to analyze the data. This article, the first in a three-part series, provides an overview and theoretical understanding of measurement system analysis using continuous gage repeatability and reproducibility (R&R) studies. |
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| Why Perform A Product D-Value Study? | White Paper | By Laurent Berliet and Silvia Rizzi, Mesa Laboratories | Follow our discussion on non-heat-sensitive aqueous liquid product sterilization and the use of the overkill method and the bioburden/BI method. |
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| Prioritize Process Validation To Mitigate Manufacturing Risks | White Paper | By Raghu Vadlamudi, Donatelle | Medical device manufacturers must prioritize process validation to ensure safe and effective performance. Neglecting this can lead to severe consequences. This article covers essential elements of process validation due diligence. |
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| Three Considerations When Introducing A New Medical Device | Article | Flexan | When a company brings a new medical device to market, the road can be long and complex. There are several regulatory concerns to navigate. Additionally, there are some very important considerations regarding manufacturing. Manufacturing processes, assembly requirements, packaging, and other factors must come into play right from the start. |
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| Current Trends In Medical Kit Packaging | Article | B. Braun OEM Division | Today’s version of the medical procedure kit comprises stackable, efficient, sterile, and identifiable trays or pouches stocked with essential equipment for specific surgeries, tests, and examinations. |
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ARTICLES YOU MAY HAVE MISSED |
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Take a look inside our ISO 13485 certified Orchard Park, NY, locations featuring two full-service facilities: one dedicated to silicone and the other for thermoplastics injection molding. |
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