Ms. Cullen’s emphasis is on Regulatory and Healthcare Compliance in the medical device and durable medical equipment industries.
Ms. Cullen has an extensive background in healthcare, including over fifteen years as CEO and President of Cullen Medical Equipment, a regional durable medical equipment company and simultaneously serving on the Executive BOD of Washington D.C. based National Association of Medical Equipment Suppliers (now AA Homecare).
In 2009 Ms. Cullen began providing field surveys for HQAA, a Medicare approved accreditation organization. She also provided consulting services to those businesses seeking to obtain or renew their accreditation. She has experience with The Joint Commission, HQAA and ACHC.
Since 2011, Ms. Cullen has worked in the Regulatory/Quality department of a Global Medical Device Manufacturing company performing internal audits both within the corporate offices and throughout North America. She also led the organization through the accreditation process. The scope of the internal audits includes; 21 CFR 820, ISO 13485, OSHA 29 CFR 1910, OSHA 40 CFR 273, DOL, DOT, HIPAA, Accreditation standards, Federal and State requirements.
