by PRO-TECH Design | Sep 12, 2022 | Articles
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...
by Aaron Swanson | Aug 8, 2022 | Articles
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...
by Aaron Swanson | Jun 23, 2022 | Articles
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...
by Aaron Swanson | Jun 6, 2022 | Articles
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...
by Aaron Swanson | May 4, 2022 | Articles
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...
by Aaron Swanson | Apr 4, 2022 | Articles
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...
