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.
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)
Office: 972.480.9554
FAX: 972.767.4325
   1201 Richardson Drive Suite 280
   Richardson, TX 75080
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.
© 2007 Ken Block Consulting. All rights reserved.
FDA & ISO Medical Device Compliance
FDA Regulatory Expert

Affairs Certification (U.S.) from the Regulatory
Kenneth L. Block has earned the Regulatory
Affairs Professionals Society (RAPS). The RAC
(U.S.) is earned through professional examination,
Kenneth L. Block has earned the Regulatory
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
Kenneth L. Block, RAC*
Ginza Fuzetsudou Bldg. 5F
6-6-1 Ginza, Chuo-ku, Tokyo Japan
Office: 03-5537-7385
Tokyo Office:
Sample Consulting Projects:
U.S. Office:
Immediate Contact: 972-480-9554
Fee structure:
Contact Information:
Domestic Hourly Rate per Specialty
International Rate per Specialty
Travel Expenses as Required