Kenneth L. Block and some of his staff have
earned the Regulatory Affairs Certification (U.S.)
from the Regulatory Affairs Professionals Society
(RAPS). The RAC (U.S.) is earned through
professional examination, regarding
comprehensive knowledge of FDA and related
U.S. regulations, policies and guidelines in the
areas of medical devices, drugs and biologics.
The RAC (U.S.) designation is a mark of distinction
for regulatory professionals dealing with FDA
products and issues including strategic planning,
design & development, pre-market & regulatory
review, manufacturing quality systems, marketing,
post-approval and FDA interfacing.
BS Physics + 20 years professional experience in
regulatory affairs, quality systems, R&D, product
and process improvements, medical device
manufacturing, validations, testing, and lasers.
Immediate Contact: 972-480-9554
© 2007 Ken Block Consulting
Service in Japan:
RAC certified native Japanese staff will visit Japan
and conduct quality audit, gap analysis, seminars,
submission assistance and other activities that you
need to have done for your Japanese contractors.