Why Calibration Matters

The concept of equipment calibration is an important one throughout FDA and ISO requirements.  ISO 9001, section 7.6 discusses it in a broad sense, while ISO 17025, “General Requirements for the Competence of Testing and Calibration Laboratories”, is specifically about calibration.  In 21 CFR 820.72, it’s stated that “Calibration procedures shall include specific directions and…

Quality Plan

In 21 CFR 820 Subpart B, the FDA states “Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured.  The manufacturer shall establish how the requirements for quality will be met.” A quality plan states the goals your company has to improve…

FDA Inspections

If your company holds a 510(k) on a device, the FDA may perform an inspection of your facility for any number of reasons including routinely scheduled investigations or response to a reported problem.  These inspections are supposed to happen at least once every two years.  There is no requirement, though, for the FDA to give…