EU MDR & IVDR Regulation: Where Does the Guidance Stand?
Companies marketing devices in the European Union are facing a perfect storm of [...]
Companies marketing devices in the European Union are facing a perfect storm of [...]
From food and beverage to electronics to CPG, there’s not a single type of manuf [...]
Software validation is historically one of the most difficult compliance activit [...]
When evaluating an automated QMS, the question to invest in configuration vs. ou [...]
The European Union (EU) Medical Device Regulation (MDR) officially went into eff [...]
EU Medical Device Regulation (MDR) has been in effect for almost a year. As anti [...]
In recent months, the U.S. Food and Drug Administration (FDA) has issued a dozen [...]
This is the second installment of a two-part series focusing on the importance o [...]
This is the first installment of a two-part series focusing on the importance of [...]