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FDA is not the only organization that can review 510(k) submissions. Under the Third Party (“3P”) Review Program, ...
We witnessed several changes in the medical device industry in the year 2018. The impact of some changes was ...
Medical Device manufacturers selling their devices in the European Union are currently in a three-year transition ...
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 ...
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 ...
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