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...