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Submitting a 510k for a medical device can be a long and confusing process. When a 510k is submitted the device ...
The COVID-19 pandemic has changed the world by disrupting global supply chains and impacting human health. This ...
A Certificate of Analysis, CoA, is a document, usually issued by an organization’s quality department, that ...
A deviation is any unwanted event that differs from the approved processes, procedures, instructions, ...
Continuous improvement is the ongoing improvement that can occur in all settings and many aspects of a company. It ...
Whether it is an SOP or a test report, there are certain practices that everyone should follow in order to create ...
Many companies in the industry have been preparing for the In Vitro Diagnostic Regulation (IVDR) rollout since it ...
Compliance and quality, while similar, can also be strikingly different. Many companies treat quality as nothing ...
Environmental monitoring is used to assess environmental conditions and trends. The FDA Aseptic guidelines state ...
The COVID-19 pandemic has demonstrated the importance of supporting and listening to science. Even two years ...
A Risk Assessment is yet another powerful tool in a professional’s arsenal that, if used effectively, can greatly ...
At EMMA International, we constantly work in a fast-paced environment, which means we are team-centric and work ...
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