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We all know how being MDSAP certified opens doors to market a device in the USA, Canada, Japan, Brazil, and ...
Direct-to-consumer (DTC) tests, such as those marketed by 23andMe, are changing the classic paradigm of health ...
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 pilot program, CMMI Institute’s role in it and how manufacturers will benefit from this program.
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-700x496.png)
Every year FDA releases an annual report for Quality system inspections and enforcement action data for the Medical
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 ...
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