SERVICES-
Medical Devices
Auk has years of experience helping firms achive FDA compliance for medical device development and manufacture. Our expertise includes:
-
Quality Management and Good Manufacturing Practices
-
Device Premarket approval (510(k) development)
-
Mock FDA inspections
-
Training
-
Initial Importer and US Agent Services
-
Software development processes and validation
Home of the industry's
Top Regulatory Compliance Experts
Auk Technical Services has been helping firms comply with FDA regulations since 2004. Our consultants have years of experience in the field, and include ex FDA investigators and state regulators.
We have expertise in:
Medical Device Regulation
Pharmaceutical Regulation
ISO Regulatory Standards
Good Manufacturing Practices (GMP)
Food Safety (FSMA)
Let us help solve your regulatory issues
ABOUT US
Contact Us
Auk Technical Services
800-640-3891
Auk Technical Services provides consulting nationwide and worldwide. We have consultants in:
-
Central Arizona
-
Northern & Southern California
-
Southern Florida
-
Northern Indiana
-
Southern Michigan
-
Utah
-
Western Washington
