Publishers of FDA compliance newsletters, manuals, CDs, and provider of full-text copies of 483s, EIRs, 510(k)s, PMA summaries and other FDA documents. We publish: * Inspection Monitor * Validation Times * Adverse Event Reporting News * Warning Letter Bulletin Compliance Manuals: * Guide to Vigilance & Adverse Event Reporting * Guide to Systems-based Inspections * 483s/EIRs on CD and DVD * 510(k)s and PMA summaries on DVD * FDA Computer Software Manual * Drug and Device Answer Book Regulatory Documents: Full text 483s, EIRs Full text 510(k)s, 510(k) summaries PMA summaries And, more!