Our mission is to assist companies develop and improve quality management systems that result in compliant and sustainable management. 

We believe that by helping your company ensure compliance, you can continue to provide quality product and services to your end users.

Our team consists of experienced FDA consultants with experience both at the Agency and in industry.  Our primary area of focus is the Medical Device Industry, specializing in*:

• Quality System Regulations (QSR)

• ISO 13485:2016

• ISO 9001:2015

• Good Clinical Practices (GCP)

*Including supporting standards and regulations.

Ashleigh Barkans has been in the Medical Device and Biotechnology Industry for over +10 years. She started her career as an Investigator with the Food and Drug Administration focusing primarily on Medical Devices. Ashleigh was with the FDA for about seven years before joining industry where she has focused on quality management systems, process development, audits, training, and regulatory strategy. Ashleigh brings extensive knowledge of both domestic and international standards and regulations as well as real world applications.