All equipment must be qualified and calibrated for its intended use.
Know how IQ, OQ and PQ—the three essential elements of a Quality Assurance System—govern the medtech sector.
In just about any industry, this is a basic part of a quality system.
Production and operations managers—make sure your preventative maintenance procedures are up to snuff.
The underlying purpose of the Medical Device Single Audit Program is to allow one of five regulatory bodies to perform an inspection and then share the results with the other agencies so additional/duplicate inspections are not required.
What is required of an FDA compliant calibration program? How about crafting a program that actually results in inspection, measuring and test equipment actually being calibrated?
This is the 21 st Century and if a device manufacturer has not figured out that gauges need to be calibrated and traceable to a national standard, e.g. NIST, then the device manufacturer is probably in the wrong business.