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EO Sterilization & Medical Device Packaging

EO Sterilization & Medical Device Packaging

EO Sterilization & Medical Device Packaging Sterilization is a critical step in the manufacture of medical devices, as it helps to ensure that the devices are free of harmful microorganisms and safe for use. Ethylene Oxide (EO) sterilization is one of the most...
The Medical Device Packaging Development Process

The Medical Device Packaging Development Process

The Medical Device Packaging Development Process When it comes to successfully commercializing medical devices, the packaging process plays an incredibly important role. This process involves various steps, such as design and layout, materials selection, sterilization...
Fundamentals of the CAPA Quality Process

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

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...