Kara & Associates
KARA & Associates Inc. offers global regulatory support to ISO 13485, ISO 14971, CE marking, CMDR, JPAL, RDC 59, and 21CFR820. The company trains, audits, and offers procedure development. KARA & Associates prepare 510(k)s and other international dossiers, including Europe, Japan, Canada, and others. The company also works with MDSS as an authorized representative for the European Union.