The EU Medical Device Regulation (EU MDR) requires more than a few new SOPs. A profound overhaul of ...
The United States of America is the largest medical device market in the world. A population’s age i...
Recently, the FDA ordered that all sales and distribution of surgical mesh for transvaginal repairs ...
The last several years have brought many changes to the medical device quality and regulatory indust...
The growth in popularity of at-home medical device diagnostic equipment has obvious benefits for con...
The transition from EU MDD (2007) to EU MDR (2017) has included an increase in expectations for medi...
Earlier this summer, Glaxo Smith Kline announced a partnership with popular take-home DNA kit compan...
With the recent updates to ISO 9001: 2015 and ISO 13485: 2016, many companies are now beginning to r...
Risk management has been getting a great deal of attention in the medical device industry recently, ...
The medical device and pharmaceutical quality industry is constantly changing, as evidenced by recen...