Kara & Associates Information

KARA & Associates, Inc. is an engineering, quality & regulatory consulting company dedicated exclusively to serve quality, engineering, and regulatory groups within all industry sectors. KARA & Associates, Inc. was founded in 1992 by a group of expert associates. Each consultant has his/her own area of expertise. Their education, broad knowledge of processes and requirements, and extensive quality, regulatory and engineering experience combines to forge a team of professionals dedicated to working with a wide variety of industries to help bring safe and effective products and services to the market in a timely and efficient manner. Our combined expertise provides extensive knowledge of various engineering regulations worldwide, as well as quality and regulatory requirements such as ISO 9001:2000, TS16949, 21 CFR Section 820 (QSRs), and ISO 13485:2003 standards, with a specialty in the European Directives for CE Marking. Our consultants are seasoned specialists who are familiar with both US and European regulations, and help clients obtain 510(k) clearances with the FDA, crisis intervention related to 483 warning letters and assistance in CE marking under all applicable European Directives such as MDD, IVDD, PPE, PV, EMC, LVD, and others. KARA & Associates, Inc. is the first in the industry to offer a unique fixed price business model and an innovative performance guarantee. We are members of RAPS, CEPS, ASQ, and other industry groups.