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News and Medical Device Packaging Insights from Pro-Tech Design & Manufacturing

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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The Essentials of Medical Device Packaging Validation

The Essentials of Medical Device Packaging Validation

Packaging validations are a critical part of the overall medical device packaging process. Validations ensure that the packaging material, sealing processes, handling and distribution meet appropriate standards to protect the integrity of the packaging and its...

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NEWS

ISO 17025 Lab Testing Accreditation

We are excited to share that PRO-TECH has been officially certified to conduct bioburden, LAL, and sterile barrier system testing at our Santa Fe Springs, CA headquarters. After months of quality testing, submissions, and a virtual certification audit, our lab is...

PRO-TECH Response to COVID-19

12/16/2020 Update Given the increase in COVID cases around the country, we wanted to provide an update as we close out 2020. We continue to be vigilant about cleaning, mask-wearing and social distancing protocols to keep our employees safe and to maintain operations....