| 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.
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 | |
| On-Site Audit (China, Taiwan, Japan, Malaysia, Thailand, | |
| Vietnam) | ||
| Quality System Audit can be performed by Native English, | |
| Japanese and Chinese. | ||
| FDA Related Seminar/Classes (Presentation in Native | |
| Languages) | ||
| 510(k) / 510(k) Exempt | |
| Quality Management System Improvements/Implementation | |
| FDA/QSR/GMP & ISO 13485:2003 Compliance | |
| Establishing Design Control & Design History | |
| Domestic/International Regulatory Strategy | |
| English/Japanese/Chinese 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 | |
| Mobile: 214.448.1859 | |
| FAX: 972.767.4325 | |
| Email: ken@kenblockconsulting.com | |
| Address: | |
| Ken Block Consulting 1201 Richardson Drive Suite 140 Richardson, TX 75080 |
*Certification:
Kenneth L. Block has 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.
Kenneth L. Block has 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.
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: 214.448.1859
© 2007 Ken Block Consulting
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