Medical Device Human Factors (MDHF), provides comprehensive human factor services to medical device manufacturers. Our services include design, evaluation, and validation of products consistent with FDA and MDR (CE mark) standards and regulations. We are ISO9001: 2015 certified.
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HirLan partners with medical device manufacturers 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 510(k)/MDR (CE Mark) Human Factors Requirements and comply with IEC 62366-1:2015 and ANSI/AAMI HE75:2009(R)2013 Human Factors Specifications.
Need an in-house Human Factors practice? Need short-term Human Factors Consulting? Have a question or two about ANSI/AAMI HE75:2009(R)2013, IEC 62366-1:2015, CE Mark and/or FDA 510(k) Human Factors Requirements? HirLan can help. In whole, or in part - with over 75 combined years of Human Factors experience, HirLan is ready to help you with your Human Factors needs. The sooner you call, the sooner we can help.
HirLan helps customers build products that meet user/customer needs and requirements. The processes that are used meet and exceed the ANSI/AAMI HE 75:2009(R)2013 and IEC 62366-1:2015 standards, as well as the FDA 510(k) Human Factors Guidance and MDR (CE Mark). The following business processes when integrated into your product development lifecycle will insure meeting these standards as well as build profitable products: ⦁ Managing the Innovation Process through effectively collecting and prioritizing Innovative Product Ideas, Requirements and Features ⦁ Software and Mobile Device Design Process and Review ⦁ User Centered Participatory Design Process ⦁ Iterative User Centered Design ⦁ Stakeholder Participatory Decision Making ⦁ Usability Testing: Evaluation (formative) and Validation (summative) ⦁ Human Factors Principles and Guidelines (ANSI/AAMI HE 75:2009(R)2013 / IEC 62366-1:2015) ⦁ Medical Device Regulations (MDR) ⦁ Vigilance Plans and Studies (Post Launch)
Do you have a Usability Engineering file? What does it look like? Can an auditory tell at a glance that you are conforming to both FDA and MDR requirements/standards? HirLan has been working with both top 10 pharma-device manufacturerers and start-ups worldwide. They have an excellent reputation with the regularatory bodies through the implementation of the their system and knowledge of the contents of a quality Usability Engineering file. We are glad to come into your organization and implement our expertise.
Both the FDA and the MDR 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 (MDR) 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:
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I am a globally recognized Human Factors expert with over 30yrs. experience.
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