Newsletter | September 21, 2023

09.21.23 -- 5 Best Practices For Responding To FDA Form 483 Inspection Observations

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Webinar: Incorporating Pressure Sensor Technology Into Catheters

Join Flexan October 3rd for an informative and in-depth exploration of the intersection between healthcare, technology, and the materials that are holding great promise for the future. This session will illuminate best practices, possibilities, and challenges when designing and manufacturing sensor-enhanced catheters that detect and measure pressures within the body, including blood pressure, intravascular pressure, bladder pressure, and more. Click here to learn more.

FEATURED EDITORIAL

5 Best Practices For Responding To FDA Form 483 Inspection Observations

How you respond to FDA Form 483 observations will determine if they escalate into more serious consequences, such as a warning letter or enforcement action. You don't want that. Follow this five-step action plan to make sure the findings are properly addressed.

INDUSTRY INSIGHTS

Best Practices For Medical Device Prototyping

A prototype is crucial for engineers to understand product functionality before production, saving time and resources, but challenges may arise during the design process.

Evaluating Relevance Of Seal Quality Inspection

Seal quality and strength are crucial and regulated for sterile medical device packaging. The package seal consists of a flexible barrier attached to the rigid container using advanced adhesive.

Repeatability Test With External Test Weights

A repeatability test with external test weights is recommended to verify balance accuracy. This operating procedure outlines the steps to perform the test.

The Benefits Of Prototyping When Manufacturing Medical Devices

Prototyping is crucial when developing new medical devices and throughout the manufacturing process. It's especially important when introducing a new device to the market.

Material Behavior At The Micro Scale: The Core Of Medical Device Innovation

Micro medical device design requires considering material behavior on a micro level. Learn about polymer mechanics and material selection in this white paper.

Top 7 Considerations To Choose The Right RFID Tag

When selecting RFID tags, consider these seven factors to find the most cost-effective and optimal performance option.

High-Volume Manufacture Of Thin-Wall Medical Device Components With LCPs

The advantages of liquid crystal polymer (LCP) thermoplastics are translatable to precision combination drug delivery devices, which incorporate complex mechanisms and wireless connected electronics.

Key Considerations For Selecting A Medical Pump

When selecting a pump for medical devices, a thorough review of pump parameters is necessary, as opposed to solely considering pressure and flow rate.

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Agile Software Development In Biopharma And Medical Devices, Part 3

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RESOURCES

Sterilization Cycle Development

Non-Magnetic, High-Power RF Capacitors And Trimmers

Brochure: Insert vs. Overmolding

ProtoTools Prototyping Tools

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