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Medical Device Packaging Validation Procedure: Overview

Medical Device Packaging Validation Procedure: Overview

Medical Device Packaging Validation Procedure: Overview According to the U.S. Center for Disease Control and Prevention, HAIs (healthcare-associated infections) affect approximately 1.7 million patients each year, resulting in over 98,000 deaths. To preserve the...

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Consolidation in Medical Device Contract Manufacturing

Consolidation in Medical Device Contract Manufacturing

Aaron Swanson, President of Pro-Tech Design, wrote an article that was featured in Medhealth Review magazine. In his article, you can discover how the medical device industry is undergoing a groundbreaking transformation with the rise of consolidation in contract...

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EO Sterilization & Medical Device Packaging

EO Sterilization & Medical Device Packaging

EO Sterilization & Medical Device Packaging Sterilization is a critical step in the manufacture of medical devices, as it helps to ensure that the devices are free of harmful microorganisms and safe for use. Ethylene Oxide (EO) sterilization is one of the most...

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The Medical Device Packaging Development Process

The Medical Device Packaging Development Process

The Medical Device Packaging Development Process When it comes to successfully commercializing medical devices, the packaging process plays an incredibly important role. This process involves various steps, such as design and layout, materials selection, sterilization...

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What is ASTM F1980 and Why Should You Care?

What is ASTM F1980 and Why Should You Care?

What is ASTM F1980 and Why Should You Care? For medical device packaging, one essential criterion is that the packaging you choose protects the device and maintains its sterile integrity over the shelf-life of the product. ASTM F1980 is the industry standard that...

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Fundamentals of the CAPA Quality Process

Fundamentals of the CAPA Quality Process

An Introduction to Medical Device Contract Manufacturing A good medical device contract manufacturer must have a rigorous quality system in place to ensure that the device is protected and safe for use.  Part of that system should include a detailed corrective and...

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How to Navigate an Audit During a Pandemic

How to Navigate an Audit During a Pandemic

For anyone in the medical device industry, ISO Audits are stressful enough and there is a lot riding on them. However, in the current situation, now you add the challenges of a pandemic and remote communication on top of it. As part of a recent renewal audit for our...

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PRO-TECH Design Purchases Minnesota Contract Manufacturer

PRO-TECH Design Purchases Minnesota Contract Manufacturer

PRO-TECH Design & Manufacturing, Inc. is returning to its roots in Minnesota.  With the acquisition of Surgical Technologies, Inc. (STI), PRO-TECH owners are deepening ties to their home state of Minnesota. The founder and CEO, Pam McMaster, started her career in...

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