Commitment To Quality

At the heart of Human Ability Designs’ approach is quality and safety centered collaborations with all our clients. As a regulatory Human Factors Engineering consultant, Melissa has worked with hundreds of clients and contributed to numerous approved pre-market and post-market Human Factors Engineering projects and submissions.

How We Work Together

We provide your team the complete human factors solution that is centered around a collaborative relationship to generate regulatory ready outputs as well as high quality scientific solutions that solve pre- and post-market human factors challenges. Your team will benefit from working with Human Ability Designs because we remain focused on solving problems and finding solutions to human factors challenges. With each client interaction, we integrate information and innovate solutions to help your team meet your goals, optimize your user interfaces, and develop sound documentation to ensure your safe and effective products will be approved during the first submission. Our reliable expertise provides the foundation of your successful regulatory journey to an approval to efficiently bring your medical product to market.

A regulator’s request for additional information, rejection, or need to rework a Human Factors Engineering process and submission will delay or impede your successful product launch. These delays are completely avoidable with the expertise of Human Ability Designs on your team. When we work together, recommended solutions will fit within your team’s existing expertise, capabilities and processes. With that in mind, suggested solutions are scalable based on your team’s needs because a cookie cutter approach to solving your challenging needs is rarely successful.

Collaboration For Regulatory Success

Human Ability Designs believes in focusing on high quality, regulatory ready, and scientific human factors approaches that will meet or exceed regulatory expectations. With Human Ability Designs, quality that leads to successful submissions is key. We don’t subscribe to thrown-together solutions or cutting corners. Working together we will ensure you efficiently bring your safe and effective products with optimized user interfaces to the market. We provide options, comprehensive information and guidance to support your team in making the best choices for the realities of your organization, end users, and first time regulatory success.

Our Philosophy

We believe regulatory Human Factors Engineering is more than obtaining the pre-market approval. It’s understanding the end users. It’s understanding the use environment. And it’s optimizing the user interface to help users easily realize the reasons your product is intended for the market. It’s also understanding how to tell your human factors story to regulatory reviewers so they can understand and approve your submission. Quality Human Factors Engineering is a focus to weave throughout the journey of design, development, and marketing of your product. Together we will focus your team's human factors solutions for the pre- and post-market phases so you can ensure ongoing user safety and market success.

Together we will find solutions, improve processes, and implement methods to ensure your regulatory and market success meets or exceeds the needs of your end users. Contact HAD and request your consultation to see how your organization can benefit from over 15 years of experience in regulatory Human Factors Engineering.

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