Medical Device Human Factors (MDHF), is dedicated to providing comprehensive human factors services to medical device manufactures. Our services include design, evaluation, and validation of products consistent with the FDA 510(k) Human Factors Guidance, the MDR and ANSI/AAMI HE75:2009(R)2013 Human Factors Engineering-Design Specifications. MDHF uses various testing methodologies and processes depending upon the stage of the product cycle (see below). MDHF also provides design and evaluation of all Medical Device ancillary materials (ie, product inserts, instructions for use, videos, etc). In addition, MDHF provides human factors regulatory support in the creation and maintenance of the usability engineering file.

Medical Device Human Factors is a service provided by HirLan, Inc.

Virginia A. Lang, PhD

President and Chief Scientist

Virginia started in the medical research field as a Coordinator of Research at the Clinical Research Unit Kennedy Institute of Johns Hopkins Medical Center. She was responsible for the initiation, coordination, and management and/or analysis of research projects in the Clinical Research Unit. These projects were funded by various Federal Government Agencies. Subsequent to Johns Hopkins Medical Center, Virginia entered the field of Human Factors through the doctoral program at SUNY Binghamton. Virginia held a fellowship at the Aeromedical Research Laboratory of the United States Air Force at Wright-Patterson AFB, Dayton, Ohio and a fellowship at NASA. Her research dealt with cognitive factors that differentially affect the characteristics of visual displays. Applications of this research are directly related to various medical devices and software applications providing Medical Device Human Factors by HirLan clients with 30 years of Human Factors experience.

In addition, Virginia has extensive experience in the areas of product design, Customer Centered Participatory Design processes, and product lifecycle management. She is also known in the Human Computer Interaction and Usability Communities for her innovative techniques for collecting and incorporating user/customer feedback throughout the product lifecycle. In July 2014, Virginia founded and established the HirLan Institute of Human Factors with labs in Carlsbad, California and a Consortium arrangement in London, UK. In February 2013, Virginia founded HirLan International SA, a Geneva, Switzerland based company. Both HirLan and HirLan International have been supporting Top Ten pharma/medical device companies, as well as, start-ups with consulting and testing services. These services are in conjunction with their clients’ FDA 510(k) and CE mark applications.

Virginia holds a PhD in Cognitive-Experimental Psychology from SUNY Binghamton, and a Master of Science (ABT) in Applied Technology, Systems Science from SUNY Binghamton.

Aimee-Marette C. Pulley, Esq.

Director of Quality/ Regulatory and Legal Counsel

Aimee serves as Director of Quality and Legal Counsel of HirLan, Inc. Aimee manages our Quality System and Processes and ensures our adherence to ISO 9001 standards. She currently holds a certification in Regulatory Affairs. Her specialties in law include: Corporate Transactions and Contracts: the formation, drafting and review of service agreements, statements of work, and other contracts for services or purchase of products; and general litigation. In addition, Aimee also has expertise in Bankruptcy, Family and Collection Law.

Aimee attended the University of Nevada-Las Vegas where she earned her Juris Doctorate (J.D.) degree at the William S. Boyd School of Law. She licensed to practice law in the states of Nevada and Georgia