See the latest blog posts from SIMCO and CERDAAC.
There are sophisticated software solutions available today that can optimize the regulated manufacturer landscape. It’s software that makes maintenance, calibration, and asset management easier, with
Although there’s a big difference between a U.S. Food and Drug Administration (FDA) Form 483 Observation and an FDA Warning Letter, both are nerve-wracking notifications
Medical device manufacturers must demonstrate adherence to strict installation, operational, and performance qualification protocols (IQ, OQ, and PQ, respectively) to ensure that the equipment used
Accurate calibration and metrology practices are the backbone of quality control in medical device manufacturing. These practices involve precise measurements and adjustments to ensure that