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All things must inevitably come to an end, including a medical device recall. Whether voluntary or FDA mandated, ...
There is an innate benefit to utilizing statistical techniques in any manufacturing process, but even more so for ...
Engaging in medical device product development requires establishing and documenting design controls. The FDA ...
The new EU MDR 2017/745 is complex, to say the least. Depending on a company’s relationship to the medical device ...
When making a new product, whether that product is a drug, a medical device, or a combination product, ...
When an error occurs, corrective and preventative actions are developed to help strengthen the quality ...
Around the world, there are different regulations regarding the cultivations, manufacture, and sale of ...
The new European Union regulation for medical devices, EU MDR 2017/745, went into effect only recently ...
Cervical cancer poses many risks to women and without regular checkups it can be hard to detect. ...
As with most highly regulated industries, the medical device industry requires high quality and safety ...
Project Management, as it is classically defined, can be described as “…the use of specific knowledge, ...
A lot of work goes into a 510k submission for a medical device. Companies that submit a 510k for a ...
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