Medical Device Human Factors, by HirLan, Inc.

Medical Device Human Factors, by HirLan, Inc. MDHF, Medical Device Human Factors, is dedicated to providing comprehensive human factors services to medical device manufactures.

The services provided to medical device companies include design, evaluation and validation of products that are consistent with the FDA 510(k) Human Factors Guidance and the ANSI/AAMI HE75:2009 Human Factors Engineering-Design Specifications. MDHF uses various testing methodologies and processes depending upon the stage of the product cycle. In other words, MDHF conducts formative evaluations and

summative validations. In addition, MDHF provides design and evaluation of all ancillary materials for medical devices, e.g., product inserts, instructions for use, and videos, etc.

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San Diego, CA

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