Manufacturing & Packaging Articles
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What Is A Robust Quality Management System And Why Does It Matter?
6/13/2022
When we talk about partnering with OEMs, we often reference the fact we have a very robust quality management system (QMS). It sounds great, but what does it mean for you and what does it mean for us on a day-to-day basis? Why is it imperative that both organizations have an understanding of each other’s QMS?
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Three Considerations When Introducing A New Medical Device
6/13/2022
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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The Benefits Of Prototyping When Manufacturing Medical Devices
6/13/2022
Prototyping is essential when developing a new medical device or component. In fact, it is crucial throughout the manufacturing process in general, and key when bringing a new medical device to market. It might be even more important for medical devices, in some regards.
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Using Liquid Injection Molding (LIM) For Medical Device Manufacturing
6/13/2022
Within the world of medical device manufacturing, liquid injection molding (LIM) is a process that provides several benefits over other methods. Product strength and reduced weight, all while being more cost effective than some other alternatives, and still producing an end product within the set parameters of the device and regulatory bodies are some of those benefits.
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The Benefits Of Design For Manufacturability
6/13/2022
Manufacturability describes the degree to which a product can be effectively manufactured, given its design, cost, and distribution requirements. However, it’s a part of the entire process of bringing a new component or medical device to market.
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The Importance Of Medical Device Packaging
6/13/2022
When designing or considering the manufacturing process for a medical device, there’s an element that often gets left until the last minute; packaging. The right packaging used can reduce costs, potentially optimize the sterilization processes, and aid in the manufacturing process.
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When Does Automated Assembly Make Sense?
6/13/2022
To mitigate costs, timeliness, and other factors, in order to produce a safe, effective, innovate medical device means assembly has to be part of the concept phase, to determine if full automation is the solution.
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Biological Indicators And The European Pharmacopoeia
5/10/2022
Here, we review the information concerning biological indicators in European Pharmacopoeia General Chapter 5.1.2, which is more detailed and covers a wider scope than the previous version.
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Why Biological Indicators Survive A Validated Cycle
5/10/2022
We review what to do should you ever find yourself in the situation where the probes indicate conditions that would render killed BIs, yet the units are testing positive.
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Flexible, Modular Manufacturing When One Size Doesn't Fit All
5/5/2022
Current drug delivery devices need to be more mobile, less intrusive, and cost-competitive. Learn how flexible, modular manufacturing aims to solve these challenges.