EXPERTS IN MANAGING HUMAN FACTORS THROUGHOUT THE PRODUCT LIFECYCLE

• Creation / Review of a stong usability engineering file
• Human Factors / Usability Testing
• Iterative Design and Testing Methods
• Human Factors Design Best Practices
• Human Factors Training/Education
• User Centered Participatory Design Methods
• Innovation Process Methods
• Business Process Consulting

HirLan partners with medical device manufacturers of all sizes (i.e., entrepreneurs through top 5 manufacturers/pharma) to assist with Human Factors Engineering through product innovation, development, evaluation (formative)/validation(summative) testing, and delivery. We specialize in the custom integration of Human Factors Best Practices into your specific product and business processes environment to meet the FDA/CE Mark (MDR) Human Factors Requirements and comply with IEC 62366-1:2015 and ANSI/AAMI HE75:2009(R)2013 Human Factors Specifications.

Syringes, Catheters, X-Ray Machines, Medical Software (EMR) - All are considered Medical Devices by all of the notified bodies. But depending upon the specific type, the classification can differ between the various notified bodies, e.g. FDA versus MDR. All medical devices are affected by Human Factors Regulations, some more than others.

Both the FDA and MDR (CE Mark) require Formative and Summative Human Factors Testing for the approval process. Formative Testing is a smaller scoped test performed at various stages throughout the Product Lifecycle to ensure product development is progressing as desired and catch usability issues early in the process. The successful Summative Test is the final Human Factors Test prior to FDA/CE Mark Approval and product release. The ultimate goal of Human Factors Engineering and all testing is to ensure Safe, Effective and Usable products are introduced to the public.

HirLan helps customers create, produce, evaluate, and validate all types of print, electronic and video product collateral meeting all ANSI/AAMI HE75:2009(R)2013 and IEC 62366-1:2015 Human Factors Requirements. HirLan’s principals actually contributed to the creation of the ANSI/ AAMI HE75:2009(R)2013 and FDA 510(k) Human Factors Requirements so you can be assured your materials and collateral will conform to the regulations upon completion. Including: Product Packaging, IFUs, Product Inserts, Instructional Videos.

HirLan

+1 (619) 301-2073
mdhf@hirlan.com

Medical Device Human Factors
c/o HirLan, Inc.
2121 Palomar Airport Road
Suite 202/203
Carlsbad, CA 92011
USA