Introduction
All laboratory testing is conducted in accordance with:
- Code of Federal Regulations
- U.S. Pharmacopeia Guidelines
- ISO/IEC 17025; 2017
- FDA Registration - #1645338
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).
- CDC Permit - #2017-07003
- USDA Permit - #52162
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.
Certificate of Accreditation
Click here to see our ANAB ISO 17025 Certificate of Accreditation
Click here to see our ASR ISO 13485 Certificate of Accreditation
