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Introduction: All laboratory testing is conducted in accordance with: Code of Federal Regulations U.S. Pharmacopeia Guidelines  ISO/IEC 17025; 2005 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. 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.

NEWS Dynatec is now ACLASS Accredited to ISO 17025: 2005 #AT-1372 Click here to view certificate     FDA Registration #1645338 Dynatec third party lab for air compressor certification to ISO 8573 via TUV America.   Please visit us at the 2012 MD&M TEXAS trade show- Booth 516! Updates CYTOTOXICITY TESTING NOW! REUSABLE DEVICE VALIDATIONS NOW AVAILABLE   Article, Medical Device Manufacturing of U.S Products in Mexico, Vol.12 No.4 in Controlled Environments Magazine Click here to view ANSI/AAMI/ISO 10993-7:2008 New Standard Biological Evaluation of Medical Devices-Part 7:Ethylene Oxide Sterilization Residuals Standard has been published. Any questions regarding the new Tolerable Contact Limit (TLC) please call Dynatec Labs at (915)849-1322 or view AAMI website. For your convenience, please see our online "Request for Testing Services Form" located at the bottom of each "Our Services" section