Dynatec Labs - The Answer To Market Advantage_About

Dynatec Scientific Laboratories, is the Medical Device Laboratory which holds
"THE KEY TO MARKET ADVANTAGE".

From product development to regulatory compliance...Let Dynatec do it all for you.

About Us

Dynatec is registered with the U.S. Food and Drug Administration (#16453338). Dynatec also holds recognition as a Small/Disadvantaged Business Enterprise with the State of Texas and the City of El Paso.

Dynatec's experienced scientists utilize validated protocols and compliance regulations to insure reliability. All laboratory testing is conducted in accordance with:

Code of Federal Regulations
U.S. Pharmacopoeia XXIII
ISO 9000 Standards

Summary of Services:
Radiation Cobalt-60 Ionizing Sterilization ANSI/AAMI/ISO 11137-CURRENT
Ethylene Oxide Sterilization ANSI/AAMI/ISO 11135-CURRENT

Aerobic Bioburden
Anaerobic Bioburden
Spore Forming Bioburden
Biological Indicator Challenge
Dose Audit Studies
Bacteriostasis/Fungistasis
Product Sterility Testing

Support Services:

Water/Wastewater Analysis
Contact Lens-Safe Medical Device Act (SMDA) Studies
Package Integrity Studies
EO Residual Analysis
Cytotoxicity
Endotoxin Testing
Clean Room Certification
Environmental Monitoring
Bacterial Identification

Professional Affiliations:

Association for the Advancement of Medical Instrumentation (AAMI)
American Society for Quality (ASQ)
American Society for Testing and Materials (ASTM)
American National Standards Institute (ANSI)
Association of Official Analytical Chemists (AOAC)
Dallas District FDA Industry Medical Device Coalition (Previous Member)

Import/Export Assitance from Mexico - Import and Export devices as well as biologicals from your facility (maquiladora) to our lab (Dynatec Labs).

On-Site Capability - Dynatec can be at your facility within the contiguous United States as well as in Mexico, within 24 hours.

Bilingual Scientist - Dynatec's Scientist are bilingual in both English and Spanish as well as interpreting reports and specification either at your facility or received at Dynatec Labs.

Internet Electronic Transmissions - In accordance with FDA CFR 21 Part 11.

Dynatec can send, to you the customer, reports in a PDF format.
Dynatec's Turn-Around Time is one of the most accurate and shortest in the industry.

In-House Workshops Available - Dynatec offers to its clients a host of in-house workshops that can vary from Cleanroom Certifications to Sterilization of Medical Devices.

Customized Medias - Dynatec offers custom medias that are made and delivered directly to you.