FDA 510K Clearance :
For medical devices classified as Class II and III, a 510K clearance is necessary in order to market the product in the US. The clearance requires compliance to the CFR, Part 820 Quality System Regulations (QSRs), Good manufacturing Practices (GMP) and the other applicable CFRs for the product type and indications for use. We provide training on GMP & can review your 510K application. We can conduct facility audit based on quality management system in compliance with the QSRs and applicable CFRs.