Design controls are not being used as an aid during medical device product development. Design controls are being viewed as a checkbox item — something you have to do, and seldom something you want to ...

An Ohio firm that is both an own-label distributor and specification developer of sterile wound dressings received a warning letter from the US Food and Drug Administration (FDA) for ongoing problems ...

Medical device startups have a pile of things to address yet often don’t have the pile of money to take care of everything that is needed. Because of this, a medical device quality system often gets ...

Recent FDA enforcement trends (including 2013) reveal that both design control and Corrective and Preventive Action (CAPA) systems are critical elements to sustain FDA inspections. Device ...

Tell us about the control strategy you've implemented with AstraZeneca and its external partners. Over the last year, we worked to improve our control strategy for drug delivery devices. Our goal was ...

Batch remains advantageous for development, variable demand, and bounded risk, benefiting from natural hold points, simpler investigations, and lower upfront capital, despite longer lead times and ...