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...

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...

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...