FDA & ISO Medical Device Compliance

Regulatory Affairs Certified*
Ken Block Consulting
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:
Sample 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:
Office: 972.480.9554
FAX: 972.767.4325
Email: ken@kenblockconsulting.com
Address:
Ken Block Consulting
1201 Richardson Drive
Suite 280
Richardson, TX  75080
*Certification:

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.
Background:

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
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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.