Medical Devices - Ken Block Consulting

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.

		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
		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.

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.

		Hourly Client Rate
		Travel Expenses as Required