Advanced has a core competency in highly controlled manufacturing methods. Advanced received ISO 13485 in 2010. In 2014, we registered with the FDA. Our first FDA inspection was in 2016 and no 483s were issued. We offer ISO Class 8 (class 100,000) cleanroom molding as well as an Animal Derived Component Free (ADCF) molding cell. We also specialize in validation protocols as required by our customers.
For MedTech and BioTech applications, we conduct installation qualification, operational qualification & performance qualification (IQ/OQ/PQ). In fact, our molding qualification process has been characterized as a best practice by several auditors and medical OEMs.
In addition to molding discipline, Advanced performs final medical device assembly which requires qualified equipment, qualified processes, and stringent documentation (e.g., device history record). This is done in an ISO Class 8 cleanroom (which is designed to and could be qualified to ISO Class 7). Disciplined assembly manufacturing also involves extensive operator training, label making and handling, line clearances, and sterile barrier packaging.