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A year-long investigation titled “Implant Files”, which was initiated by the ICIJ (International Consortium of ...
The purpose of this webinar is to discuss the FDA’s voluntary medical device manufacturing and product quality ...
The FDA’s 510(k) process for medical devices is doing a lot of rounds in the news lately. This includes the FDA ...
![A Brief Analysis of Medical Device Quality System Enforcement Actions [2015 -2017]](https://emmainternational.com/wp-content/uploads/2018/11/AnalysisOfMedicalDevice_Blog-gap.png)
Every year FDA releases an annual report for Quality system inspections and enforcement action data for the ...
The revision of the Quality System Regulation [QSR] (21CFR 820) which was a priority set in FDA’s Spring unified ...
The digital health software pre-certification program is FDA’s strong footstep in leading the way to support the ...
Medical devices in the UK are regulated by the directives put forth by the EU, including:
Active Implantable ...
In a previous blog from a few months ago on the update in the De novo pathway, we shed some light on the prices ...
EpiPen Shortage
Kids are going back to school all over the country. For many kids, an EpiPen (epinephrine ...
The future of enterprise quality management software is changing. Quality professionals across the globe are ...
Paper Based QMS vs EQMS
When looking at a document management system, companies have two choices; paper based or ...
As a quality and regulatory consulting firm in the Life Sciences space, we work with innovators, product ...
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