Newsletter | May 11, 2021

05.11.21 -- The Top 10 Most-Cited Issues In FDA FY2020 Medical Device Inspections | Using System Risk Structures

 
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Less Is More: How LEAN Processes Can Bolster Profits And Sustainability

LEAN manufacturing is an important extension of controlled operations that comes with benefits in limiting costs, boosting profits, reducing waste, and improving sustainability. But how can device manufacturers learn, adopt, implement, and make LEAN manufacturing principles part of everyday operations?

Trimmer Capacitor Considerations In Practice

Trimmer capacitors are variable components used to calibrate RF circuits during manufacturing or servicing. These components allow for variable tuning—think oscillator frequency values or rise and fall times. Should values drift over the life of the device, trimmer capacitors can be recalibrated.

Manufacturing Process: Tools For A Successful Startup

Medbio offers a number of tips to follow for a successful startup in designing and producing injection-molded parts. 

Key Considerations For Selecting A Medical Pump

Newcomers to medical device design may think that pressure and flow rate are sufficient parameters to consider when it comes to selecting a pump. While this may be the case in some industrial applications, medical device requirements are a bit more demanding. A thorough review of the selection criteria for a medical pump is required to ensure the correct pump is chosen for every application.

Medical Device Tyvek Seal Quality And Peel Strength

Class III medical devices must maintain product sterility for the duration of the product’s shelf-life and must be easy to open. Tyvek seal strength is critical for a product to survive transportation, shipping, and storage. Peelability of the pouch is equally as critical, providing those in a surgical environment the ability to deliver a device effectively into the sterile field while maintaining sterility. 

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