FDA’s postmarket regulations follow a medical device from production and processing to packaging and distribution to immediate and long-term performance in the market. Medical device manufacturers must establish and maintain a comprehensive “quality system” to ensure their devices are manufactured consistently to specifications set by FDA, and they must establish and maintain thorough reporting mechanisms to detect, identify and mitigate any device-related problems.
“Those reports are constantly collected, and companies are required to track and trend everything,” says Dr. Susan Alpert. Additionally, FDA is constantly collecting, tracking, and trending its own data.
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14 окт 2024
