Collateral Development That Meets the FDA’s 510(k) and CE Mark Guidance

Product Collateral

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:

  • Product Packaging
  • Information for Use (IFU)
  • Product Inserts (PI)
  • Instructional Videos

will conform to the regulations upon completion. HirLan specializes in:

  • Product Collateral Design and Production (print, electronic and video)
  • User Centered Participatory Design Process Seminars
  • FDA 510(k) Human Factors/Usability Testing: Evaluation and Validation