About Dynatec Labs

Dynatec Scientific Labs has been serving the medical device industry since 1989. Dynatec holds recognition as a Small/Disadvantaged Business Enterprise with the State of Texas and the City of El Paso. Dynatec offers bilingual scientists that are fluent in English and Spanish. Dynatec’s experienced scientists utilize validated protocols and compliance regulations to insure reliability and can help you with interpreting reports and specifications.

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

Import/Export Assistance From Mexico

  • Import and Export devices as well as biologicals from your facility(maquiladora) to our lab (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.

Customized Medias

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

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 Affliations

  • 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)

On Site Capability

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

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.

Professional Organizations