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...
Published Articles by Aaron
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...
The Essentials of Medical Device Packaging
On the surface, it may seem that providing proper packaging for anything is straightforward. You need a box, maybe some packaging material, and a label. However, when you are talking about packaging medical devices that may be implanted into a patient, it quickly gets...
5 Tips to Find a Trusted Medical Device Contract Manufacturer
Outsourcing assembly and packaging of products to contract manufacturers is very common in the medical device industry. Most medical device OEMs are adept at designing new products, but their expertise is not in the assembly, packaging, and sterilization of these...
2022 – Making the Case for a Positive Outlook
It might seem counterintuitive for some given all the negative headlines as we kick off the new year, but we have a positive outlook on 2022. Sure, supply chain issues will still be with us for a while and Covid doesn’t seem to want to go away. However, we view these...
Medical Device Contract Manufacturing – Supply Chain Agility
The supply chain has become a sensitive topic lately. It is not a subject that most of us typically pay much attention to—that is until things aren’t working smoothly. In medical device contract manufacturing, we’ve felt the shortages very acutely. We assemble and...