How Strong Design Controls Simplify Compliance and Eliminate Audit Anxiety
Achieving regulatory compliance is a hurdle for medical device manufacturers. Missteps and inefficiencies addressing FDA, ISO, and other regulatory directives can result in delays, warning letters, and even business closure. Design controls are at the heart of the FDA’s quality system regulation specified under Title 21 CFR Part 820. For medical device companies, adhering to quality standards throughout the new product development and introduction (NPDI) process requires strong design controls.
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