Kenneth L. Block, RAC*
Services to Medical Device Companies Worldwide:

Many medical device companies lack the experience or staffing in
regulatory affairs, quality systems, and validations needed for
FDA/ISO compliance. Services are offered at reasonable rates to
assist companies in ensuring the design, development, and
manufacturing of safe and effective medical devices for U.S. and
international markets.
Fee Structure:
Example Consulting Projects:
Hourly Client Rate
Travel Expenses as Required
Quality Management System Improvements/Implementation
FDA/QSR/GMP & ISO 13485:2003 Compliance
Establishing Design Control & Design History
Domestic/International Regulatory Strategy
Japanese/English Medical Device Translations
Company Registrations & Product Listings
Medical & Laser Product Regulatory Submissions
Software Validations (Product/Design/Process/Quality)
Hardware Validations (Fixture/Test/Process/Packaging)
Product Validations (Performance/Sterility/Aging/Shipping)
Training (GMP/Quality Systems/ISO/Validation)
Contact Information:

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
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.
Ken Block Consulting
1201 Richardson Drive
Suite 160
Richardson, TX  75080
© 2007-2015 Ken Block Consulting
FDA & ISO Compliance
US Market Entry
Inspection Support