We recently participated in FDA inspections using the new QMSR (Quality Management Systems Regulations). These inspections were very interesting. One was conducted at a foreign client in China the other was in the USA. These inspections went directly to the QMSR and expected that the companies were following the new regulations. If you are already
ISO 10993-6 Update: Implantation Test Methods for Medical Devices ISO 10993-6 is part of the ISO 10993 series, a globally recognized framework for the biological evaluation of medical devices. Specifically, Part 6 focuses on implantation studies, which are designed to assess the local effects of medical devices or materials when placed within living tissue. These
FDA UPDATE The new QMSR and the FDA inspections – be aware!!!! IN a few short weeks, a major change in the FDA regulations pertaining to the manufacturing of medical devices since 1997 will go into effect. The FDA is changing the Quality System Regulations (QSR) to the Quality Management System Regulations (QMSR). What does
GMP vs. ISO There has been a great deal of confusion concerning whether being in compliance with the medical device Good Manufacturing Practices (GMP) would successfully lead to obtaining ISO certification (with minimum changes and costs), or whether achieving ISO certification is going to be a long, expensive road. The ultimate success of your ISO
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