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Testimonials - Human Centered Strategies
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Submission and Protocol Reviews. Human Factors Strategy and Process Reviews. Bob’s deep expertise in medical human factors enables him to deliver value to clients in hours that would take almost anyone else days. He knows the device world and the regulatory world and most importantly, he knows how to help clients be successful where these two worlds converge. He is the dom. Patricia A. Patterson. Evan T. Edwards. Vice President, Product Development and Industrialization. Edmond Israelski, PhD. Vice Presi...
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Submission and Protocol Reviews. Human Factors Strategy and Process Reviews. Jan 29, 2016. Over the past two years, we are seeing a number of companies be audited by FDA regarding adherence to their own Design Controls procedures. In particular, validation is the topic, or actually, failure to validate! Post Market Data: Valuable Source of Human Factors Problems. Feb 23, 2015. Post Test Inquiry: What if there are no use errors? Jan 5, 2015. Colorado Springs, CO 80908. Edmond Israelski, PhD.
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Human Centered Strategies - Dr Robert North Consulting
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Submission and Protocol Reviews. Human Factors Strategy and Process Reviews. Streamlining your FDA human factors approval process. You know that the FDA requires Human factors for the approval of most medical devices and combination products. How will you comply with these requirements in an expedient manner, avoiding costly delays in the approval process? Do you have the evidence necessary to demonstrate that your device design has addressed use risk problems? Webinar on Guidance Available.
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Standards / Guidances - Human Centered Strategies
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Submission and Protocol Reviews. Human Factors Strategy and Process Reviews. The links below will direct you to the current standards and guidances. These are essential to understanding the Human Factors and Usability process for medical devices. Guidance for Industry and Food and Drug Administration Staff –. Applying Human Factors and Usability Engineering to Medical Devices. FDA Combination Product Testing Guidance. List of High Priority Devices for Human Factors Reviews. This standard is under current...
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Submission and Protocol Reviews - Human Centered Strategies
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Submission and Protocol Reviews. Human Factors Strategy and Process Reviews. Submission and Protocol Reviews. Pre-Market Human Factors Submissions and Summative Testing Protocols. Many products and devices going through the FDA pre-market approval process will require documentation of your human factors work. Both FDA/CDER and CDER have established guidelines on how to organize this information. Device and combination product manufacturers often are concerned that their human factors activities have not ...