ARTICLES & NEWS
News and Medical Device Packaging Insights from Pro-Tech Design & Manufacturing
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...
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...
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...
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...
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...
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...
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....
PRO-TECH Named to “Top Packaging Company” list by MedTech Outlook!
MedTech Outlook, a medical device industry publication, announced its annual winners for the “Top Packaging and Sterilization Companies”. PRO-TECH Design is one of the featured winners and the company is spotlighted on the cover of the November 2020 issue. The...
PRO-TECH featured in Device Alliance Podcast!
The Device Alliance, an Orange County, CA-based medical device network, interviewed Pam McMaster (CEO) and Aaron Swanson (President) for their podcast. It was a great conversation and covers a lot of topics related to medical devices and packaging. Pam and Aaron talk...