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ARTICLES & NEWS

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

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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The Essentials of Medical Device Outsourcing

The Essentials of Medical Device Outsourcing

Outsourcing production and assembly of medical devices is a common practice in the medical device industry and this article will delve into the top reasons why. 1. Lower Initial Investment For medical device companies, a key benefit of outsourcing is that they don’t...

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The Essentials of Medical Device Assembly

The Essentials of Medical Device Assembly

Let’s start at the beginning and define our topic – “Contract Assembly” refers to an OEM (Original Equipment Manufacturer) outsourcing the assembly of a medical device to a third-party. A select group of companies called Contract Manufacturers provide this unique...

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NEWS

PRO-TECH Attending 2021 MD&M West

We're thrilled to announce that we’ll be participating at MD&M West August 10 – 12. Come see us at Booth 2454. MD&M West brings together medtech engineers, business leaders, disruptive companies, and innovative thinkers to create powerful solutions and...

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...